Monitoring Drug Policy Reform - A Tracking Tool for British Columbians

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(last updated July 20, 2010)

PTF Recommendation	PSD Status Report As of July 9, 2010	BPC Comments and Recommendations	Performance measure(s) being tracked by BPC
Recommendation #1: Priority attention should be focused on development of an enhanced Formulary Management (FM) System together with improved stakeholder engagement and appeal mechanisms. This work should be led by the Pharmaceutical Services Division and include meaningful engagement with stakeholders, including patients, healthcare professionals, disease specialists, research leaders and industry.	Developed the enhanced FM system including the submission sponsor engagement process as established and presented on November 28, 2008 at the Deputy Minister’s Multilateral Stakeholder Session. Trial of enhanced sponsor engagement started in November 2008 (30 submissions trialed to date) Scheduled implementation of the enhanced FM system in January/February 2010.	The full implementation of the FM system will be incomplete as a number of the PTF recommendations and PSD framework plan have yet to be completed, such as: patient review component is incomplete; not enough experts recruited to the DRRTs, generic drug pricing issue unresolved; long-term pharmacy agreement not in place, among others. The Better Pharmacare Coalition has been told the PSD will invite Coalition representatives to meet in late February/early March 2010 to help develop patient review mechanism. BPC met with the PSD on January 29, 2010 and reiterated the following recommendations: Reinforce Government’s commitment as stated in PTF Recommendations that “patient interests are paramount” and do not delay implementation of patient review mechanism until spring/summer 2010 as reported at December 1, 2009 Multi-lateral Stakeholder meeting; List Patient Review as a parallel track with the other review elements of enhanced drug review process; Implement the Better Pharmacare Coalition recommendations on patient recruitment to patient registry as shared on March 13, 2009, December 14, 2009 and January 29, 2010. Update: The Better Pharmacare Coalition submitted a response to the PSD following the April 27th meeting regarding the patient review process. At a meeting on June 10, 2010 we were told that implementation is planned for summer 2010.	Patient Review

Recommendation #2: The Ministry of Health Services (the Ministry) should act to establish new target review/listing decision guidelines with the goal of substantially improving BC’s performance on time-to-listing decisions. Progress on this front must be publicly reported and consistently benchmarked against the performance of other jurisdictions.	New target timelines developed as established and presented on November 28, 2008 at the Deputy Minister’s Multilateral Stakeholder Session. Begin tracking timelines within new DBC/DRRC/DRRT process by February 2010 and will be reported annually.	As stated repeatedly by the BPC and other stakeholders at the Multi-lateral consultations, the PSD’s proposed target review times are unsatisfactory in that they do not achieve enough of a performance improvement to meet the needs of patients in BC. At the October 30, 2009 meeting with the PSD, the Coalition asked if they would benchmark against other jurisdictions and were told that the information is not publicly available. The BPC is unclear how the PSD intends to do this given it was specified in the recommendation.	Timelines

Recommendation #3: The Drug Benefit Committee should be reconstituted as the Drug Benefit Council to more appropriately reflect the arm’s-length role it is expected to carry out in the review processes applicable to consideration of new therapies.	Completed November 2008 (as presented during the 2008 DM Multilateral Stakeholder Session).	The BPC did receive information at their meeting with the PSD in Fall 2009 confirming the DBC has been reconstituted, but details were not forthcoming. For example, information on the expertise balance of the DBC was not provided. The PSD needs to make this information available to the public to ensure that the process is both accountable and transparent to the public.	Meeting with DBC public members/professional members

Recommendation #4: The Ministry should establish a new Drug Review Resource Committee to carry out the drug submission review role currently performed by the Therapeutics Initiative (TI). This new review committee should also provide for a registry of experts that will substantially widen the array of expertise available to offer advice and recommendations on the therapeutic value and cost-effectiveness of new drug therapies.	The Drug Review Resource Committee (DRRC) and Drug Review Resource Teams (DRRT) structures will form the basis of the enhanced drug review process. Build DRRC/T Secretariat Resources (complete May 2009) The DRRT roster is scheduled to be established in December 2009. Implement DRRC (February 2010) Build rosters of reviewers for core inputs: Clinical Practice Review (Dec 09) Clinical Evidence Reviews (Dec 09) Pharmacoeconomic Reviews (Dec 09) Patient input (Spring/Summer 2010) Establish new contract with the Faculty of Medicine (Dec 09), includes building and maintaining roster of clinicians for the Clinical Practice Reviews of DRRT.	The PSD informed the BPC that only four reviewers of those who responded to their request for proposal to serve on DRRTs were qualified and accepted, and that contracts were being negotiated with those four. The PSD also informed the BPC that two of the four are members of the Therapeutics Initiative. Further, the PSD informed the BPC that the DRRC would in essence be operated by the UBC, not the PSD. The decision to do this is neither transparent nor accountable to patients or the public. BPC is not clear how the PSD intends to structure the registry for experts or how clinical expertise will be incorporated into the reformed drug review process.	Re-issue RFP for DRRC registry of experts & Patient Review

	Update: Draft RFQ has been sent to stakeholders for input by July 30th	Update: The BPW will be submitting feedback to the Draft RFQ.
Recommendation #5: The membership of the Drug Benefit Committee should be modified to include the participation of at least three public members selected through process external to the Ministry. Government may also wish to consider ensuring that at least one member of the Drug Benefit Committee has broad economic expertise to supplement the existing expertise that is focused more narrowly on health economics. BRDO member search (Mar 09) Ministerial appointments (Dec 09) Member training (Jan 10) 1st DBC meeting (Jan 10) DBC has been formed and orientation is taking place.	BPC is not clear how PSD will conduct clinical evidence or pharmacoeconomic reviews. On January 29, 2010 the Better Pharmacare Coalition was informed that the DBC terms of reference and conflict of interest guidelines will be posted on the government website. At this January 29, 2010 the Better Pharmacare Coalition also requested to meet with the DBC public members – or full committee – before the end of March 2010. A meeting invitation has not been issued to the BPC to date.	Patient Review & Meeting with DBC public members/professional members

Recommendation #6: No members of the TI or, in the alternative, no participant in a Drug Coverage Review Team should participate as members in the work of the Drug Benefit Council.	Completed November 2008 (as stated during the November 2008 DM Multilateral Session). Confirmed that 10 RFP’s received, four were selected and two are TI members.	DBC members have now been announced, but DRRT members have not.	Meeting with DBC public members/professional members

Recommendation #7: The Ministry should initiate a negotiation process with drug manufacturers and with representatives of community pharmacy and pharmacists to establish new price and reimbursement arrangements and increased competition in respect of generic pharmaceutical products. If the parties are unable to conclude an acceptable agreement within six months, the government should move unilaterally to address the needs of the Province through legislation or through other means.	Update On July 9, 2010 the Government announced the long-term pharmacy agreement. The price of generic drugs in BC will drop to 35 per cent of the brand price, resulting in up to $170 million a year in savings for the health system. Will be effective July 28, 2010 and be phased in over two years. Professional allowances will continue.	BPC met with the PSD on January 29, 2010 and reiterated the following recommendations: Negotiate pricing with generic drug manufacturers commensurate with pricing in other jurisdictions. Failing successful negotiation by March 30, 2010, legislate generic drug price reductions to 30% of patented medicine prices; Reinvest savings into innovative and breakthrough drugs that merit listing on the BC PharmaCare drug reimbursement formulary, and provide reasonable remuneration to pharmacists for cognitive services; The Better Pharmacare Coalition has recommended that the new cost of generic medications be no more than 30 per cent of brand name medication costs The Better Pharmacare Coalition has also consistently recommended that the business model that allow for “professional allowances” or rebates generic medication manufacturers pay to pharmacies should be completely abolished.	Long-term Pharmacy Agreement & Generic Pricing

Recommendation #8: To increase the level of overall funding transparency, negotiations with pharmacists and community pharmacy should provide for a new framework for compensation in respect of dispensing and other professional services provided by pharmacists. The framework should address those professional services that can be effectively and efficiently provided by pharmacists and should be linked to transparent accountability agreements to maintain and, ideally, improve point-of-care services to patients.	Update See Recommendation #7	BPC met with the PSD on January 29, 2010 and reiterated the following recommendations: The Better Pharmacare Coalition recommends, except in safety related incidences (e.g. drug-to-drug interactions not known by the prescribing physician), to eliminate the practice of therapeutic substitution, both in existing BC PharmaCare policy and in the Long-term Agreement; The Better Pharmacare Coalition recommends that fees for cognitive services provided by Pharmacists be considered under the Long-Term Agreement. Update See Recommendation #7	Long term Pharmacy Agreement

Recommendation #9: The Ministry should adopt a cautious approach to broadened utilization of tendering processes. The process adopted should mirror tendering processes used in other areas of government characterized by a process that is transparent, fair, open, and includes understandable evaluation criteria. Increased tendering should provide for reasonable levels of patient choice, avoid the deployment of older inferior products and, where possible, arrangements that provide for participation of multiple suppliers.	The issue of tendering is deferred for the term of the Interim Agreement. Not discussed at Multi-lateral stakeholder meeting on December 1, 2009	The BPC does not support horizontal tendering across a class of medications, which forces patients to switch medications that are chemically different. The BPC does support tendering processes for drugs that have been shown to be chemically identical (such as generics). The BPC recommends that BC PharmaCare should work closely with the Purchasing Commission, a BC health economist expert in the area of unintended consequences of tendering, and other experienced procurement bodies to examine the ramifications of tendering and consider the examples in other countries such as New Zealand before making decisions on procurement and tendering. All tenders should be evaluated across the board by the various stakeholders affected, focusing on the impact on patients and the ability for physicians to provide quality care. The BPC has been assured by both the past and present Minister of Health Services that tendering is not an option.	Generic Pricing

Recommendation #10: The Deputy Minister of Health Services should commit to participate in an annual accountability session to hear from patient groups, from industry and from other key stakeholders regarding improved relations and the strengthening of the common objectives of patient care and choice.	Meetings held: July 2008 November 2008 December 2009 2010 meeting to be determined

Recommendation #11: Given that BC was a lead jurisdiction in calling for the implementation of the Common Drug Review, action should be taken to: Ensure BC’s decision-making processes include similar timelines to those used by the Common Drug Review and a greater level of commitment to openness and transparency; and that any unnecessary overlap between the Common Drug Review and BC formulary management system are reduced to the fullest extent possible.	Timelines for BC reflect those presented during the November 2008 DM Multilateral Stakeholder meeting (see PTF Recommendation #2) Avoiding overlap with the Common Drug Review is part of the current and ongoing standard drug review process in BC. BC review target timelines will be similar to CDR (see PTF Rec #2) Note: BC timelines include both review time and implementation time; CDR timelines only include review times. Overlap with Common Drug Review is avoided as part of standard drug review process in BC	The PSD’s review timelines should not be benchmarked against the Common Drug Review. They are separate processes reviewing different things. To the BPC’s knowledge, no concrete evidence has been provided to stakeholders to show that review overlap has been discontinued.	Timelines

Recommendation #12: Subject to Recommendation 4, if the TI is maintained, action must be taken in the following areas: The governance, membership and accountability standards associated with the operation of the TI will require substantial improvement; Steps must also be taken to renew and revitalize the panel of experts the TI relies upon to discharge its obligations; The function of the TI should be focused on therapeutic evaluation. Activities beyond that core mandate, such as public education, should be reassigned to the Ministry’s Drug Utilization Branch where an accountable process can be implemented to assure unbiased and evidence-based practices; The practice of having members of the TI also participating in the work of the Drug Benefit Committee should be terminated.	Restructuring of the Faculty of Medicine contract to include a roster of clinicians for Clinical Reviews is scheduled to be completed in December 2009. See PTF Rec #4 (DRRT)	This renewed contractual relationship was never discussed with stakeholders and is in complete contravention of the PTF recommendations. At the November 28, 2008 Multi-lateral Stakeholder session, a drug review framework was presented and discussed by stakeholders in attendance. At no time was a contract to house what appears to be the bulk of the review process at UBC and the Department of Anesthesiology, Pharmacology and Therapeutics discussed, nor was it discussed in no fewer than three subsequent bilateral meetings with the PSD. In our last correspondence following our March 13th meeting with David Morel, the BPC sought clarification on how the PSD plans to ensure the objectivity of an independent and arms-length drug review body such as the DRRTs and mitigate a potential continuation of TI bias in the drug review process. We did not receive a response to this request. We learned at our October 14th meeting with the Minister of Health Services where we were told by Bob Nakagawa that in fact a new contract has been struck with UBC and it appears the bulk of the review in that framework from Nov. 28th stakeholder meeting has changed significantly to now include a new contract with the Department of Medicine, which will rely on the Division of Anesthesiology, Pharmacology and Therapeutics to address what appears to be the bulk of the drug review process. This is a significant departure from previous stakeholder consultations.

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