<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_416"
                     title="For Diabetes, P4P Improves Patient Care, Outcomes (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/PracticeManagement/Reimbursement/tb/18328?impressionId=1265815026840"
                     
      &lt;p&gt;Measures of quality of care and clinical outcomes improved significantly when diabetic patients in a large private health plan were treated by physicians receiving pay-for-performance incentives, researchers said.&lt;/p&gt;
&lt;p&gt;The risk that diabetic patients would be hospitalized was 25% lower (incidence rate ratio 0.75, 95% CI 0.61 to 0.93) among those seen for three consecutive years by physicians who received extra pay for meeting quality-of-care targets, compared with the risk for patients whose physicians did not receive such incentives, reported Judy Ying Chen, MD, MSHS, of IMS Health in Woodland Hills, Calif., and colleagues.&lt;/p&gt;
&lt;p&gt;High-quality care  --  defined as receiving at least two tests for glycated hemoglobin (HbA1c) and one for LDL cholesterol during a given year  --  was delivered 16% more often by physicians in the pay-for-performance system (rate ratio 1.16, 95% CI 1.11 to 1.22), the researchers also reported online in the &lt;em&gt;American Journal of Managed Care&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;This study showed a robust, consistent, significant, and positive association between increased receipt of appropriate laboratory monitoring of A1c and LDL cholesterol levels and decreased hospitalization rates,&quot; Chen and colleagues declared.&lt;/p&gt;
&lt;p&gt;On the other hand, the researchers also found that quality of care diminished when patients saw multiple primary care physicians during a given year.&lt;/p&gt;
&lt;p&gt;&quot;This finding supports the hypothesis that patients have better outcomes when they have a medical home,&quot; Chen and colleagues indicated.&lt;/p&gt;
&lt;p&gt;The researchers examined records of diabetic patients enrolled with Hawaii Medical Services Association, a large preferred provider organization, from 1999 to 2006. The plan had about 19,600 such patients in 1999 and 32,365 in 2006.&lt;/p&gt;
&lt;p&gt;The plan offered physicians in the network the opportunity to earn bonuses of 1.5% to 7.5% of their base fees for meeting care-quality targets including HbA1c and LDL cholesterol testing of diabetic patients. Bonuses ranged from $10,000 to $16,000 annually. Starting in 2001, physicians could earn an extra $6,000 if their adherence to care-quality processes improved over the previous year.&lt;/p&gt;
&lt;p&gt;Bonuses were paid each year on the basis of administrative records for the previous year.&lt;/p&gt;
&lt;p&gt;The proportion of diabetic patients seen by physicians in the pay-for-performance plan increased from 78.7% in 1999 to 94.6% in 2006.&lt;/p&gt;
&lt;p&gt;As a result of the bonus structure, Chen and colleagues observed, improvements in care quality lagged implementation of these incentives by a year or two.&lt;/p&gt;
&lt;p&gt;The most substantial improvements in quality of care and patient outcomes were seen among patients seen continuously by a physician participating in the pay-for-performance system from 2004 to 2006.&lt;/p&gt;
&lt;p&gt;Compared with patients seen by physicians who chose not to participate in the system, those whose treatment was subject to the incentives were seen by primary care physicians and endocrinologists far more often: &lt;ul&gt; &lt;li&gt;Six to 10 outpatient visits in a year: odds ratio 2.16 (95% CI 2.00 to 2.33)&lt;/li&gt; &lt;li&gt;Eleven or more outpatient visits in a year: OR 2.35 (95% CI 2.14 to 2.57)&lt;/li&gt; &lt;li&gt;Visit to an endocrinologist: OR 1.56 (95% CI 1.38 to 1.75)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Among patients receiving quality care continuously from 2004 to 2006, the chance of being hospitalized in 2006 was reduced by 33% compared with patients whose care failed to meet the quality target at some point (rate ratio 0.67, 95% CI 0.61 to 0.75).&lt;/p&gt;
&lt;p&gt;But patients who saw more than two different primary care physicians in 2006 had a dramatically increased rate of hospitalizations (RR 6.13, 95% CI 5.33 to 7.04).&lt;/p&gt;
&lt;p&gt;Chen and colleagues noted several limitations to the study, including the fact that it was conducted in a PPO setting and might not be generalizable to health maintenance organizations or other frameworks.&lt;/p&gt;
&lt;p&gt;The researchers also had no data for years before the program started, leaving open the possibility that physicians participating in the pay-for-performance program were those who were already following treatment guidelines.&lt;/p&gt;
&lt;p&gt;The study also included only one clinical outcome; effects on others such as hypoglycemic episodes, cardiovascular events, and meeting HbA1c targets were not measured and might have been different.&lt;/p&gt;
&lt;p&gt;The researchers also acknowledged that the claims data underlying the study might not have been totally accurate, and they noted that it did not include other factors known to affect hospitalizations such as cardiovascular risk factors.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by the Hawaii Medical Service Association, the health plan that was the focus of the work.&lt;/p&gt;&lt;p&gt;IMS Health is a healthcare consulting firm that, among other services, advises health insurers on performance and quality programs.&lt;/p&gt;&lt;p&gt;Several co-authors were employees of the Hawaii Medical Service Association, and officials of the group reviewed the manuscript before submission. But the authors declared that the association had no influence on the study design, analysis, or results reported. No other potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_3419"
                     title="AAO: CMS Payment Cuts for Eye Drug Called Counterproductive"
                     score="-0.006"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAO/tb/16639?impressionId=1265815026840"
                     
      &lt;p&gt;SAN FRANCISCO  --  The recent cut in Medicare reimbursement for intravitreal bevacizumab (Avastin) will hurt both patients and taxpayers by forcing a shift to more expensive options, according to American Academy of Ophthalmology officials.&lt;/p&gt;
&lt;p&gt;The rule change that went into effect on Oct. 1 created a code to account for the tiny doses used in ophthalmology, requiring practices to bill in 0.25 mg increments at $1.25 each.&lt;/p&gt;
&lt;p&gt;That dropped reimbursement for the standard 1.25-mg intravitreal dose from about $50 to $6.25.&lt;/p&gt;
&lt;p&gt;Reimbursement for its competitor ranibizumab (Lucentis)  --  a closely related molecule generally considered to have equal efficacy  --  remained unchanged at a whopping $2,039.&lt;/p&gt;
&lt;p&gt;Since ranibizumab costs under $2,000 for a single dose, ophthalmologists usually make around $120 with each injection.&lt;/p&gt;
&lt;p&gt;But even at the prior reimbursement level, they usually didn&apos;t profit from choosing bevacizumab.&lt;/p&gt;
&lt;p&gt;One vial of bevacizumab  --  originally developed for cancer treatment  --  contains more than one intravitreal dose, but drawing multiple doses from the same container almost doubles the risk of infection.&lt;/p&gt;
&lt;p&gt;So, compounding pharmacies divide up the drug into individual doses, repackage, and sterilize them  --  but at a price that typically pulled even with reimbursement before the Oct. 1 cut.&lt;/p&gt;
&lt;p&gt;So the new rule actually creates a disincentive for using the drug that has been estimated to save Medicare $1.5 billion each year in treating macular degeneration alone, said William Rich, MD, the medical director for health policy at the AAO.&lt;/p&gt;
&lt;p&gt;The AAO and other ophthalmology organizations immediately started negotiating for a change that would reflect compounding charges, he said.&lt;/p&gt;
&lt;p&gt;One argument for the new rule is that CMS cannot legally pay for pharmacist costs, but that&apos;s not true, according to Rich, who said it is allowed for some asthma and pain management treatments.&lt;/p&gt;
&lt;p&gt;Early talks were positive but led nowhere except to a Congressional inquiry, according to George Williams, MD, of William Beaumont Hospital in Royal Oak, Mich., and a member of the AAO Health Policy Committee.&lt;/p&gt;
&lt;p&gt;&quot;We thought we had a solution,&quot; he told retinal surgeons at the AAO meeting here. After daily talks with CMS, &quot;we were told two weeks ago it would be fixed. Two weeks have passed, and it is still not fixed.&quot;&lt;/p&gt;
&lt;p&gt;Sen. Herb Kohl, D-Wis., who chairs the Senate Committee on Aging, has demanded an explanation for the change and questioned the role of Genentech, which manufactures both drugs and would stand to gain financially from greater use of its more expensive product.&lt;/p&gt;
&lt;p&gt;The company has denied any part in the CMS decision, according to media reports. But Kohl has reportedly asked for a copy of all communication between CMS and Genentech.&lt;/p&gt; 
&lt;p&gt;CMS officials met with the Senate Committee on Aging today and said there were plans to rectify the situation with new coding rules expected to come out later this week.&lt;/p&gt;
&lt;p&gt;However, exactly what the changes would be and when they would occur remained unclear, according to Kohl&apos;s committee staff.&lt;/p&gt;
&lt;p&gt;However, Rich was skeptical that CMS would have a remedy in place soon.&lt;/p&gt;
&lt;p&gt;&quot;If the current policy is left in place, physicians lose, patients lose, and taxpayers lose,&quot; he said.&lt;/p&gt;
&lt;p&gt;He has already heard reports of some ophthalmologists switching to the more expensive drug in order to avoid losing money. Because most patients with conditions treated off-label with bevacizumab are on Medicare, their 20% copays have increased dramatically.&lt;/p&gt;
&lt;p&gt;&quot;Physicians who changed are getting tremendous pushback from patients,&quot; Rich said.&lt;/p&gt;
&lt;p&gt;He urged a quick solution to avoid the shift in practice patterns from becoming set. As of 2007, bevacizumab held about 60% of the market share.&lt;/p&gt;
&lt;p&gt;&quot;We&apos;re not interested in assigning blame, we just want to get it fixed&quot; Rich said.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_1377"
                     title="No SGR Overhaul Likely for Early Years of Healthcare Reform"
                     score="-0.007"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/14046?impressionId=1265815026840"
                     
       WASHINGTON, May 5 -- Medicare&apos;s sustainable growth rate (SGR) system for setting reimbursements might see some tweaks across the next three years, but wholesale change is unlikely in the early years of healthcare reform, said Sen. Max Baucus (D-Mont.).
              &lt;p&gt; 
              &lt;p&gt;Than means physicians can expect Medicare payment rates to remain steady over the next few years. After that, Medicare payments may grow at a &quot;neutral&quot; rate, but some physicians might experience a little &quot;bump up&quot; in pay after broader healthcare reforms take root, Baucus told reporters during a Monday press call.
              &lt;p&gt; 
              &lt;p&gt;The SGR, an arcane formula created in 1997 to calculate Medicare physician payments, was enacted to limit spending on physician services. It is based on Medicare administrators&apos; calculation of the costs to physicians of providing services in different locations.
              &lt;p&gt; 
              &lt;p&gt;Every year, the SGR formula calls for cuts in most reimbursement rates, and every year, physician groups plead for Congress to override it -- thus far successfully.
              &lt;p&gt; 
              &lt;p&gt;Without legislative action this year, physicians would face a 21% reimbursement cut in 2010 and an additional 6% annual decrease for several years thereafter. 
              &lt;p&gt; 
              &lt;p&gt;While Baucus, along with most other lawmakers, has said the SGR is broken, a permanent fix won&apos;t happen right away, he said. 
              &lt;p&gt; 
              &lt;p&gt;&quot;We&apos;ll patch it up these first three years, but after that we&apos;ll modify it and let some of the reduction in SGR match the curve, but then physicians will be compensated by the cost-sharing gains we&apos;ll receive from some of these other reforms,&quot; said Baucus, chairman of the Senate Finance Committee, the main committee taking on healthcare reform. 
              &lt;p&gt; 
              &lt;p&gt;&quot;That is just a proposal,&quot; he cautioned. &quot;We&apos;re trying to reform the SGR in a way that is consistent with overall healthcare reform.&quot; 
              &lt;p&gt; 
              &lt;p&gt;Baucus and Sen. Charles Grassley (R-Iowa), the ranking Republican on the Finance Committee, released a paper last week outlining a number of payment options being considered as part of healthcare reform. 
              &lt;p&gt; 
              &lt;p&gt;The paper presented two options that would change the SGR slightly during the next few years.  
              &lt;p&gt; 
              &lt;p&gt;Under one option, physicians would see 1% increases in payment in 2010 and 2011, and no increase in 2012. By 2013, a new law would likely be in place to replace the old system. 
              &lt;p&gt; 
              &lt;p&gt;The second option would also adhere to the 1% increase in 2010 and 2011, and no increase in 2012, and adhere to the current law in 2013, but it would allow no physician see a reimbursement cut greater than 3% per year. 
              &lt;p&gt; 
              &lt;p&gt;Beginning in 2014, localities that have two-year average fee-for-service growth rates that are at or greater than 110% of the national average could see cuts in payment of up to 6%. 
              &lt;p&gt; 
              &lt;p&gt;Another policy option outlined in the paper would give primary care physicians and general surgeons in rural areas an extra 5% Medicare payment bonus for five years. It would also give a bonus to primary care practices that provide care to high-cost beneficiaries with chronic illnesses. 
              &lt;p&gt; 
              &lt;p&gt;In the paper, the senators outline a plan to move away from a fee-for-service model and begin implementing value-based purchasing for hospitals first, and then for physicians. 
              &lt;p&gt; 
              &lt;p&gt;The senators also outlined a plan to &quot;bundle&quot; care. 
              &lt;p&gt; 
              &lt;p&gt;By 2015, hospitalizations and all post-acute care that a given patient receives for 30 days after discharge would be bundled in one Medicare payment. According to the paper, bundling care will encourage providers to work together to improve patient care, rather than just focusing on treating the patient in a piecemeal approach. Hospitals that reduce admissions under the approach would receive Medicare payment incentives. 
              &lt;p&gt; 
              &lt;p&gt;Another option would add to the current Physician Quality Reporting Initiative (PQRI) by increasing incentive payments for physicians who participate in a qualified American Board of Medical Specialties certification and complete a qualified Maintenance of Certification practice assessment. The current PQRI program rewards physicians for reporting data, but a performance-based reward system is already in the works. 
              &lt;p&gt; 
              &lt;p&gt;The paper was the first of three to be released before the Finance Committee begins marking up a healthcare reform bill in June. 
              &lt;p&gt; 
              &lt;p&gt;Vivek Murthy, M.D., an internist at Brigham and Women&apos;s Hospital in Boston, told Baucus during the Monday call that many physicians back the senator&apos;s reform efforts. 
              &lt;p&gt; 
              &lt;p&gt;&quot;As a physician community, we are here to support you in any way we can on getting healthcare reform done for our country this year&quot; said Dr. Murthy, president and co-founder of Doctors For America, a grassroots group that claims 11,000 members.
              &lt;p&gt; 
              &lt;p&gt;The press call was organized by the Center for American Progress. 
    </recommendedItem>
    <recommendedItem id="20090101_19_1834"
                     title="ADA: Wal-Mart, Mail-Order Pharmacies Top Affordable Drug List"
                     score="-0.007"
                     href="http://www.medpagetoday.com/MeetingCoverage/ADA/tb/14611?impressionId=1265815026840"
                     
      NEW ORLEANS, June 9 -- Diabetes patients who shop for the best prices on prescription drugs at mail-order retailers and big-box discounters may save thousands of dollars a year, researchers found.
              &lt;br&gt; 
              &lt;br&gt;In an analysis of pricing data obtained from state attorneys general, Medco by Mail and Wal-Mart were the least expensive, while neighborhood and chain pharmacies generally charged the most, Clifton M. Jackness, M.D., and Ronald Tamler, M.D., Ph.D., both of the Mount Sinai School of Medicine in New York, N.Y., reported.
              &lt;br&gt; 
              &lt;br&gt;&quot;Being an informed consumer is clearly beneficial,&quot; they said here at the American Diabetes Association meeting.
              &lt;br&gt; 
              &lt;br&gt;The total monthly out-of-pocket price for all 10 drugs most commonly prescribed to diabetes patients for any indication ranged from a low of $428.35 with Medco to a high of $641.90 with Rite Aid. 
              &lt;br&gt; 
              &lt;br&gt;The researchers speculated that lower costs may improve adherence, and thus outcomes, since nearly one in five adults with diabetes reports cutting back on their prescriptions because of cost.
              &lt;p&gt; 
              &lt;p&gt;However, there is often a tradeoff for lower prices, commented R. Paul Robertson, M.D., ADA&apos;s president of medicine and science.
              &lt;p&gt; 
              &lt;p&gt;&quot;Pharmacies, especially local ones, offer more than drugs,&quot; he said. &quot;They offer service and the opportunity to talk to a pharmacist.&quot;
              &lt;p&gt; 
              &lt;p&gt;Giving that up in exchange for a lower bill may be worthwhile for some patients who are on a stable regimen and familiar with their medications, whereas for others it might not, Dr. Robertson noted.
              &lt;p&gt; 
              &lt;p&gt;The researchers tabulated the most common prescriptions filled by diabetes patients under age 65 (a population expected to have at least some out-of-pocket cost associated with their medications) from a medical and pharmaceutical claims database compiled by 91 health insurance plans across the U.S.
              &lt;p&gt; 
              &lt;p&gt;After exclusion of nonchronic medications such as antibiotics, the top medications in order of number of prescriptions were: 
              &lt;p&gt; 
              &lt;ul&gt;
                &lt;li&gt;Metformin
                &lt;li&gt;Atorvastatin (Lipitor)
                &lt;li&gt;Lisinopril (Prinivil, Zestril)
                &lt;li&gt;Rosiglitazone (Avandia), excluded from the analysis because of declining use since the time covered by the database
                &lt;li&gt;Furosemide (Lasix, Furocot)
                &lt;li&gt;Pioglitazone (Actos)
                &lt;li&gt;Simvastatin (Zocor)
                &lt;li&gt;Hydrochlorothiazide (Microzide)
                &lt;li&gt;Insulin glargine (Lantus)
                &lt;li&gt;Amlodipine (Norvasc)
                &lt;li&gt;Atenolol (Tenormin)
              &lt;/ul&gt;
              &lt;p&gt; 
              &lt;p&gt;While this list contained several duplicate classes, such as multiple antihypertensives and two statins, Dr. Jackness noted that diabetes patients take an average of 8.9 medications. The typical patient would be on the majority of drugs on the list, he said.
              &lt;p&gt; 
              &lt;p&gt;The cost of a 30-day supply of each -- assuming no prescription drug coverage by public or private insurance -- was determined from the New York and New Jersey State Attorneys General. 
              &lt;p&gt; 
              &lt;p&gt;These offices maintain publicly-accessible Web sites on current prescription drug prices at the pharmacies in their respective states. The researchers confirmed the prices by direct contact with the pharmacies.
              &lt;p&gt; 
              &lt;p&gt;For some drugs, the price differences between pharmacies were dramatic. 
              &lt;p&gt; 
              &lt;p&gt;Consider metformin, the 10th most popular generic drug prescribed overall in 2008, with 40 million prescriptions written, according to &lt;em&gt;Drug Topics&lt;/em&gt; magazine
              &lt;p&gt; 
              &lt;p&gt;Dr. Jackness and colleagues found that metformin sold for $4.00 in the generic drug discount program at Wal-Mart and Target and for $5.00 at Kmart. But the local neighborhood pharmacies averaged $38.95 and pharmacy chain Rite Aid charged $39.99.
              &lt;p&gt; 
              &lt;p&gt;While stores such as Wal-Mart have heavily marketed their low-cost generic programs, they tended to offer more competitive prices for nongeneric drugs as well.
              &lt;p&gt; 
              &lt;p&gt;And, although the superstores and mail-order pharmacies did not consistently offer lower prices for every medication, none of the local chains or independently-owned pharmacies had the lowest price for any drug on the list. 
              &lt;p&gt; 
              &lt;p&gt;When prices for the 10 drugs most commonly prescribed to diabetes patients were added (excluding rosiglitazone), the monthly totals were:
              &lt;p&gt; 
              &lt;ul&gt;
                &lt;li&gt;$428.35 for Medco by Mail (excluding shipping and handling)
                &lt;li&gt;$432.53 for Wal-Mart
                &lt;li&gt;$483.94 for Kmart
                &lt;li&gt;$501.65 for Drugstore.com (excluding shipping and handling)
                &lt;li&gt;$505.95 for Target
                &lt;li&gt;$584.44 for CVS
                &lt;li&gt;$633.11 for Duane Reade
                &lt;li&gt;$638.31 for Walgreen&apos;s
                &lt;li&gt;$639.20 for local pharmacies
                &lt;li&gt;$641.90 for Rite Aid
              &lt;/ul&gt;
              &lt;p&gt; 
              &lt;p&gt;Unfortunately, this kind of price information is not readily available in most other states, commented Patricia Coon, M.D., of the Billings Clinic in Billings, Mont.
              &lt;p&gt; 
              &lt;p&gt;Nevertheless, savvy patients and physicians can find this information locally by doing their homework, Dr. Coon said.
              &lt;p&gt; 
              &lt;p&gt;&quot;They do a lot of shopping from pharmacy to pharmacy to get the lowest price,&quot; said Dr. Coon, who was not involved in the study. &quot;It&apos;s not unusual for patients to be asking to be switched to generics or the generic that&apos;s offered by a Wal-Mart or large brand.&quot;
              &lt;p&gt; 
              &lt;p&gt;Dr. Jackness agreed, noting that even if it&apos;s not posted in a central location, price information is available with a phone call. &quot;People shouldn&apos;t assume a drug is the same price everywhere,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt;In his own New York City practice, Dr. Jackness said he often recommends low-priced local outlets to patients at financial risk. &quot;If we see patients without insurance we tell them to go down to Penn Station and go to Kmart,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt;But realizing the savings from purchasing all medications at a superstore or mail-order company may not be possible for all patients, the researchers noted.
              &lt;p&gt; 
              &lt;p&gt;&quot;The patient must have the physical ability and means of transportation to travel to these stores or order online,&quot; they said.
              &lt;p&gt; 
              &lt;p&gt;They cautioned that the study did not take into consideration insurance coverage, which may limit generalizability.
              &lt;p&gt; 
              &lt;p&gt;But regardless of patients&apos; insurance status, the findings should serve as a wakeup call for physicians to take an active role in ensuring patients are able to obtain their prescribed medications, Drs. Jackness and Tamler concluded.
              &lt;p&gt; 
              &lt;p&gt;If adherence is an issue, physicians should ask patients about the impact of medication costs and suggest cost-lowering strategies, Dr. Robertson agreed.
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;The researchers reported no funding or conflicts of interest.
              &lt;p&gt; 
              &lt;p&gt;Drs. Coon and Robertson reported no conflicts of interest.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
              
    </recommendedItem>
    <recommendedItem id="20090101_19_3160"
                     title="Evidence-Based Drug Coverage Decisions Workable (CME/CE)"
                     score="-0.007"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/Medicare/tb/16307?impressionId=1265815026840"
                     
      Publicly-run healthcare systems have successfully used data on comparative effectiveness and cost-effectiveness for drug therapies to make coverage decisions, said researchers who studied policies in Canada, Australia, and Great Britain.&lt;br&gt;
&lt;br&gt;&quot;Perhaps the main lesson from the experience of the three countries is that systematic, durable, and widely accepted decisions can be made using comparative effectiveness and cost-effectiveness,&quot; wrote Braden Manns, MD, and Fiona Clement, PhD, of the University of Calgary in Calgary, Alberta, and colleagues.&lt;br&gt;
&lt;br&gt;Writing in the Oct. 7 &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;, the researchers added that these countries have also found ways to incorporate other criteria, such as clinical need for niche populations, into their coverage decisions.&lt;br&gt;
&lt;br&gt;Manns and colleagues said the experience of the three English-speaking nations might inform the current U.S. debate on whether and how to incorporate comparative effectiveness and cost-effectiveness data into healthcare reform.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;They noted that the Medicare and Medicaid systems generally do not take cost into consideration in making coverage decisions. Partly as a result, the annual cost to taxpayers for drugs in these programs is likely to approach $1 trillion in the next five years, the researchers said.&lt;/p&gt;
&lt;p&gt;In Canada, Australia, and Britain  --  each of which have national healthcare systems, though the structures differ considerably  --  government agencies perform evidence-based reviews of drugs to determine what the national systems will provide.&lt;/p&gt;
&lt;p&gt;Canada established the Common Drug Review (CDR) in 2002 to standardize prescription drug coverage, which previously had been established by each province individually. Manufacturers file applications with the CDR, which considers safety, effectiveness, and cost-effectiveness in comparison with other available therapies.&lt;/p&gt;
&lt;p&gt;CDR decisions are not binding on drug plans, which are still run at the provincial level, but they are followed about 90% of the time, Manns and colleagues said.&lt;/p&gt;
&lt;p&gt;Great Britain relies on the National Institute of Health and Clinical Effectiveness (NICE) to perform similar reviews, called guidances, which are binding in England and Wales (but not in Scotland). NICE considers drugs and other therapies on its own initiative as well as responding to manufacturer submissions.&lt;/p&gt;
&lt;p&gt;In Australia, drug coverage decisions are under the control of the Pharmaceutical Benefit Advisory Committee (PBAC), which makes recommendations to the nation&apos;s health minister. Unfavorable PBAC findings are binding, although the minister can still deny coverage for a drug recommended by the committee.&lt;/p&gt;
&lt;p&gt;The three bodies began making records of their deliberations public earlier this decade. Manns and colleagues examined records for all drug coverage decisions made during this period, totalling 121 for the CDR, 282 for the PBAC, and 97 for NICE. Many of the NICE decisions covered multiple drugs, such that it made a total of 199 drug appraisals.&lt;/p&gt;
&lt;p&gt;The researchers found that substantial clinical uncertainty  --  that is, when safety and effectiveness data were based on nonrandomized trials or the agencies found fault with the design of randomized trials  --  was common among drugs reviewed in Canada and Australia (42% and 44% of cases, respectively).&lt;/p&gt;
&lt;p&gt;Such uncertainly was less common for drugs reviewed by NICE (27%, &lt;em&gt;P&lt;/em&gt;=0.009), &quot;perhaps reflecting the fact that NICE typically evaluates classes of drugs that have had regulatory approval for longer,&quot; Manns and colleagues wrote.&lt;/p&gt;
&lt;p&gt;Uncertainty in the economic evidence was also common, the researchers found. Cost-effectiveness was typically measured in quality-adjusted life-years (QALY).&lt;/p&gt;
&lt;p&gt;&quot;When a cost-per-QALY estimate was required for the decision, considerable economic uncertainty existed for 46.1%, 58.2%, and 55.7% of submissions considered by NICE, PBAC, and CDR, respectively,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;But in one-quarter of cases considered by the three agencies, clinical uncertainty was the sole reason for the economic uncertainty.&lt;/p&gt;
&lt;p&gt;Approval rates were markedly higher in Britain (87%) than in Canada (50%) or Australia (54%). In the latter two countries, clinical or economic uncertainty tended to predict rejection, the researchers said.&lt;/p&gt;
&lt;p&gt;The three agencies often disagreed. For 91 submissions to two or more of the bodies covering the same drugs for the same indications, the following kappa coefficients for agreement on funding recommendations were found: &lt;ul&gt; &lt;li&gt;CDR versus PBAC: 0.27&lt;/li&gt; &lt;li&gt;NICE versus PBAC: 0.13&lt;/li&gt; &lt;li&gt;CDR versus NICE: 0.55&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The researchers said Canada was especially hard on &quot;me-too&quot; drugs for a given indication, whereas Australia tended to focus heavily on price for new agents in categories with multiple existing drug options. NICE, they said, had &quot;an apparent intention ... to find limited niches for drugs rather than recommending not to list.&quot;&lt;/p&gt;
&lt;p&gt;Manns and colleagues also examined the outcomes of agency reviews of three specific drugs: insulin glargine (Lantus) for diabetes, ranibizumab (Lucentis) for macular degeneration, and teriparatide (Forteo) for osteoporosis.&lt;/p&gt;
&lt;p&gt;Insulin glargine was rejected by the CDR because of its high price. It was accepted by the PBAC only after the manufacturer revised its application four times  --  and then only on condition that it drop the price. NICE approved the product for patients with type 1 diabetes and a small subset of type 2 diabetics for whom it was expected to be more effective than cheaper insulin products.&lt;/p&gt;
&lt;p&gt;Ranibizumab was approved by all three agencies. Manns and colleagues found that the committees had each calculated that the cost-effectiveness was good  --  the severe implications of blindness meant that the QALY savings were high, despite the drug&apos;s high annual cost.&lt;/p&gt;
&lt;p&gt;All three agencies were dissatisfied with evidence backing teriparatide, because the submitted evidence relied on placebo control rather than head-to-head comparisons with bisphosphonates. Consequently, the CDR and PBAC both rejected the drug, and NICE recommended it only for patients with severe osteoporosis with inadequate responses to bisphosphonates.&lt;/p&gt;
&lt;p&gt;Manns and colleagues said the chief lesson for the U.S. is that the very existence of these agencies &quot;confirms that it is feasible to [consider] comparative effectiveness in pharmaceutical reimbursement decisions. The successful establishment of the CDR, which operates in an environment of multiple payers, all with varying budgets, is particularly relevant to the U.S.&quot;&lt;/p&gt;
&lt;p&gt;The researchers also argued that the differences between agencies and their ultimate decisions is evidence that comparative and cost-effectiveness decision-making can be tailored to local circumstances.&lt;/p&gt;
&lt;p&gt;Finally, Manns and colleagues said, the experience with ranibizumab shows that expensive drugs can gain approval even when economics are taken into account.&lt;/p&gt;
&lt;p&gt;They suggested that the NICE approach, in which outright rejections are rare but recommendations are often limited to specific patient subgroups where the evidence for cost-effective benefit is strongest, is further proof that cost-effectiveness is not an inflexible barrier.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The Canadian Agency for Drugs and Technologies in Health funded the study. Study authors also received support from the Canadian Health Services Research Foundation, the Alberta Heritage Foundation for Medical Research, and the Canadian Institutes for Health Research.&lt;/p&gt;&lt;p&gt;No potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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