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NOTICE & COMMENT TRANSPARENCY IN THE PRICE REVIEW PROCESS In December, the Board received the second recommendations to make the price review report of its Working Group on Price Review process more open and transparent. Issues, a report on the Board’s price review process for new-patented medicines. At its !PROPOSALS FOR NOTICE AND meeting on March 5, 2001, the Board COMMENT considered the report in detail and reached a decision for further action. Transparency - Guiding principles Overall, the Board agrees with the Working Group’s recommendations. The Board The Working Group’s report demonstrates appreciates that some of these its endorsement of the Board’s commitment recommendations validate the existing to ensure transparency in its work. To practices in a number of areas. Although demonstrate the Board’s commitment to some of the more specific recommendations transparency, it proposes to formally can be implemented without further recognize the following principles: consultation, the Board has decided that it wishes to consult more broadly on the to be open and transparent in implementation of those recommendations reviewing the prices of patented that may have a wider effect. drugs; The Board is, therefore, publishing through to respect the confidentiality of this document, specific proposals to information; and implement the Working Group’s to continue to promote voluntary compliance by patentees. ...
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N O T I C E& CO M M E N T
TRANSPARENCY IN THE PRICE REVIEW PROCESS In December, the Board received the secondrecommendations to make the price review report of its Working Group on Price Reviewprocess more open and transparent. Issues, a report on the Board’s price review process for newpatented medicines.At its !PROPOSALS FOR NOTICE AND meeting on March 5, 2001, the Board COMMENT considered the report in detail and reached a decision for further action. Transparency Guiding principles Overall, the Board agrees with the Working Group’s recommendations.The Board The Working Group’s report demonstrates appreciates that some of these its endorsement of the Board’s commitment recommendations validate the existing to ensure transparency in its work.To practices in a number of areas.Although demonstrate the Board’s commitment to some of the more specific recommendations transparency, it proposes to formally can be implemented without further recognize the following principles: consultation, the Board has decided that it wishes to consult more broadly on the • tobe open and transparent in implementation of those recommendations reviewing the prices of patented that may have a wider effect. drugs; The Board is, therefore, publishing through • torespect the confidentiality of this document, specific proposals to information; and implement the Working Group’s • tocontinue to promote voluntary compliance by patentees. The Working Group report is available from the PMPRB website athttp://www.pmprb cepmb.gc.ca, under Working Group on Price Review Issues, Report.
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!THE BOARD INVITES COMMENTS ON THESE AMENDMENTS TO THE COMPENDIUM The Compendium of Guidelines, Policies and Practices is amended by adding the following section before the “Introduction”: Preamble The Board is committed to making the price review process more open and transparent to all stakeholders. Transparency plays a significant role in the area of pharmaceutical pricing in terms of accessibility of information to all Canadians in order to assist them in the decision making process regarding drug use.Increased transparency and openness in the Board’s processes can contribute to fostering an environment that facilitates evidencebased decisionmaking for stakeholders, researchers, policymakers, and most importantly, the Canadian public. In pursuit of the principle of transparency, the Board will continue to respect the confidentiality of information.The Board will also continue to promote voluntary compliance by the patentees. The Compendium is amended by adding the following after para. 4.2 of the “Introduction”: 4.3 Section87 of the Patent Act protects from disclosure information supplied by patentees and potential patentees pursuant to the mandatory reporting provisions in the Regulations and sections 80 and 82, or to a Board Order pursuant to section 82, or filed in the context of a proceeding under section 83.This provision aims to protect commerciallysensitive information, as well as some publiclyavailable information, for instance, exfactory foreign prices.However, the PMPRB does not consider that this privilege would extend to information and material collected by the PMPRB itself, and the analysis performed by its Staff of that information. 4.4 Althoughthe price review is carried out partly using the patentee’s submission and privileged information, the status of the price review process performed by the PMPRB and the consequent compliance status of patentees and applicants following the regulatory processes administered by the PMPRB, are not, in and by themselves, information supplied by patentees. 4.5 Thatinformation and the review by the Staff and by the HDAP and other experts is considered to be new information generated by or on behalf of the PMPRB.Portion of the information which is directly derived from patentees’ submissions is privileged and will remain confidential.Portion of information stemming from other confidential material supplied by patentees and which has not been made public, will remain also confidential. Privilegedor confidential information will not be made public without the consent of the patentee, or in the context of an excessive price hearing and proceedings under section 83.
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Reporting on price reviews of new patented medicines !THE BOARD INVITES COMMENTS ON THE PROPOSALS TO "publish summary reports of the reviews by Board Staff of new patented medicines for purposes of applying the Guidelines; "implement this practice, at first, by publishing reports for new active substances; "implement this practice effective for new patented medicines introduced as of January 1, 2001; and "report the relevant price tests for all new patented medicines in lieu of reporting the category designation. Board Staff apply the Excessive PriceThe Board agrees with the Working Group Guidelines in reviewing the prices of all newand proposes to begin publishing summary patented medicines.These reviews include,reports on the results of the price review for among other things, a comprehensivepurposes of applying the Guidelines. scientific analysis, often including the advice of the Human Drug Advisory Panel (HDAP),Although some Working Group members and comparisons of the price and cost of thewere of the view that the price review of all drug relative to other therapies and otherdrug products, including new dosage forms countries. TheBoard agrees with theand strengths, should be published, the Working Group that information concerningBoard has decided that it might not be the outcome of the price review should bepractical to do this, especially at first.Of the made publicly available when the review isnew drug products introduced in a given completed. year,it is the new active substances that are In its report, the Working Group referredlikely to be most important both from a favorably to examples provided with thetherapeutic, and price or cost perspective. Road Map for the Next Decadesummary reports on the results would. The includean appropriate description of the Summary reviews for Cozaar and Fosamaxbasis for the selection of comparators and are included in the appendix to thecomparable dosage regimens, and a document “Category 3 Drug Prices:summarized rationale of the Human Drug Preliminary Outline of Issues” found on theAdvisory Panel (HDAP) where it has been web site under Publications,Road Map forconsulted, as well as references to the Next Decade.in the public domain, such as information studiesand reports, which have been relied For reference, a copy of the Lipitor summaryupon to formulate the recommendation.The appears at the end of this document.Board has requested that the staff do further workon the issue of making public expert opinionthat is relied upon.The summary reportwould also include a disclaimer or noticeexplaining clearly the purpose for whichthe review was conducted.
In its report, the Working Group noted that although categories are assigned to determine the price test to be applied, they are often perceived to provide an assessment of value.In its view, it is less important to use the current numerical designation than to provide more information on the rationale for the price tests that were used and for the comparators and dosage regimens selected.In addition, it thought that such information would be more transparent, would provide more relevant information and would avoid misunderstandings.
!Commentson the Notice and Comment proposals should be forwarded to the Secretary of the Board no later thanJune 30, 2001, at the following address: !Box L40 Standard Life Centre 333 Laurier Avenue West th 14 floor Ottawa, Ontario K1P 1C1; or By fax: (613) 9527626; or By email:sdupont@pmprbcepmb.gc.ca
The Board agrees with the Working Group that information on the status of the price review of individual drug products should be made publicly available.The web site list of newpatented medicines for 2001 will include a new column, which will provide information on the status of the price review for each patented drug product.Watch for this change with the monthly update in September 2001. The Board also agrees with the Working Group that is should, as much as possible, use “plain language” in all its publications. There will be ongoing efforts to make documentation more user friendly.To the extent possible, documentation will be made available directly from the web site.
expertise and that the conflict of interest measures currently in place for the HDAP are sufficient.No changes will be made in these areas. There are currently three members of the HDAP, but there are circumstances where fewer than three may participate in a recommendation. TheBoard accepts the Working Group’s recommendation that the HDAP should have a quorum of three members whenever it reviews a new drug product. TheBoard is considering how best to achieve this objective and has directed its staff to study this matter further.
OTHER BOARD DECISIONS ON THE WORKING GROUP’s RECOMMENDATIONSIssues related to the scientific assessment of new drugs The Working Group endorsed a number of the current measures governing the Human Drug Advisory Panel (HDAP).It agreed that its members have a generalist base of
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The Working Group did not reach consensus on the submission of many patentees that they be able to present additional scientific expertise directly to the HDAP. Underthe Guidelines, the HDAP makes recommendations, which are used by Board Staff for purposes of applying the Guidelines. BoardStaff ensure that all scientific information relied on by the patentee, along with other information that may be identified, is made available to the HDAP. The HDAP is not a decisionmaking body. Its recommendations and the Guidelines are not binding on patentees.If a dispute involving a scientific evaluation of a new drug resulted in the price being outside the Guidelines and therefore it became the subject of a hearing, the patentee would have the full opportunity to call evidence and defend its position before a panel of the Board. Forits part, Board Staff would be required to provide evidence that the price was excessive for purposes of thePatent Actand would likely rely on the evidence of one or more members of the HDAP and other experts as may be required.To invite patentees to make oral submissions to the HDAP would risk turning the independent scientific advisory process into a preliminary hearing process.If patentees were permitted to make submissions in person to the HDAP, other stakeholders would expect the same opportunity.Under the current circumstances, the Board has decided that the current practice of no direct access to the HDAP remains appropriate. Input by nonindustry stakeholders In the Road Map for the Next Decade, the Board noted the submissions of some stakeholders that they be provided a greater opportunity to input into the review of new drugs by Board Staff.The Working Group
identified several options in this regard, including options whereby the Board would invite input in the course of individual drug reviews, but made no recommendations.All Working Group members could live with the option based on increased transparency through the measures described above. On balance, the Board has concluded that it would not be necessary to propose going further at this time.The Board currently receives additional information or seeks it out if necessary in the course of a review. By publishing more comprehensive information on the drugs under review and their status, and by ultimately reporting the results of the review, the Board expects that persons who have additional information will not hesitate to communicate it. The Board and all stakeholders will need some time to adapt to these changes and determine if they meet their needs. Therefore the Board proposes to evaluate all of these changes in two years time to determine if they adequately meet the objectives of transparency and openness of the price review process. Time lines The Board agrees with the Working Group that it should establish milestones and time frames for the price reviews of newpatented drugs. Workis ongoing to establish critical points to lay the groundwork for eventual milestones and time frames.Progress will be reported in future editions of the NEWSletter. Eventualproposals for milestones and time frames will be the subject of future consultation.
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Excerpt of the appendix to the document “Category 3 Drug Prices: Preliminary Outline of Issues” o the Road Map for the Next Decade, September 1998
Lipitor (atorvastatin)Lipitor (atorvastatin) is sold by WarnerLambert Canada. It was introduced in Canada in March 1997. The introductory prices set by the patentee for each strength were reviewed by the Board and found to be within the Guidelines; the price of Lipitor was within the range of the prices of the other “statins” already on the market. th Atorvastatin is the 5entry in the therapeutic class referred to as the “HMG CoA reductase inhibitors” (also known as “the statins”).It is used to reduce cholesterol and triglyceride levels in the blood, a condition referred to as hyperlipidemia.It is supplied in tablets of 10 mg, 20 mg and 40 mg.The example provided looks at the comparators used in the price review of Lipitor 10 mg. The following information was taken into consideration in setting out the TCC: I. Thetypes of drugs that are used for this indication include the statins, fibrates, bile acid sequestrants and nicotinic acid; II. Inaccordance with the Board’s Guidelines, the TCC for Lipitor was limited to the other th drugs in the same 4level ATC class i.e. the other statins; all comparators are solid oral dosage forms; III. Theintroductory prices of the other “statins” were reviewed previously by the Board and found to be within the Guidelines .Mevacor (lovastatin) was the first statin to be reviewed by the Board.It was classified in 1988 as a category 2 drug product.The prices of other drugs used to reduce cholesterol and triglycerides were taken into consideration when the first statins were reviewed. IV.ipitor (atorvastatin) may have a greater effect on triglyceride levels than the other statins. Nevertheless, all statins are considered to be clinically comparable for purposes of the TCC.Lipitor: Comparison to other drugs used in the treatment of hyperlipidemia1 Drug (Brand nameper day) Dosageregimen Cost AtorvastatinLi itor$1.60m dail 10 FluvastatinLescolm dail 20$0.75 Lovastatin (Mevacor) 20mg daily$1.73 PravastatinPravachol 10m dail$1.51 SimvastatinZocor 10$1.80m dail 1 Thismedication is administered on a chronic basis, therefore the coster dawas used as the basis for cost comarison with the comarators.NB: Drugcost based on publicly available prices in the Ontario and/or Québec formulary.
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