The drug review process in BC: A critique

Dissatisfied with the Therapeutics Initiative, a group of physicians has identified three areas of concern that they believe would, if properly addressed, ultimately improve the health of British Columbians.

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The authors have met on two occasions to discuss the current drug review process in British Columbia. We are dissatisfied with, and have concerns about, the Therapeutics Initiative. Individually, we have discussed our concerns with the government, Pharmacare administrators, the University of British Columbia, the Therapeutics Initiative, and collectively with the drug industry. The group shares common interests both in evidence-based decision making and ensuring that our patients have full and fair access to the most effective medications for their diseases.

After a review of what is known about how new medications are evaluated in this province, group members discussed their personal experiences and shared their individual concerns. At our last meeting we agreed that these concerns were substantial and that we should do whatever we could to effect a change in the current system. As a first step we wish to publicize these concerns in the hope that an open dialogue will follow with an eventual collaborative redesign of the current process.

In formulating our list of three major concerns, we acknowledge the difficulty in meeting population health needs fairly under resource constraints and the impossibility of obtaining consensus on any principles capable of resolving disputes about rationing.[1] Nonetheless we believe that by addressing the following three concerns the health of British Columbians ultimately will be improved.

The current system lacks openness

A fair process requires a clear, complete, and public statement about the rationales that play a part in decision making.[2] Transparency is the hallmark of any fair process and all stakeholders, including patients, physicians, government, and industry are entitled to full justification for any decisions that limit patient access to medications.

Transparency must extend to the criteria for the selection of experts and other participants in the process. Their compensation, institutional allegiances (for example, the relationship between the Therapeutics Initiative and UBC and between Pharmacare and the Therapeutics Initiative), and all budget and financial arrangements must be in the public domain.

We believe that the current absence of transparency raises troublesome and unanswered questions about independence and bias, which adversely affects the integrity of the whole process.

The current process is selective in the information it uses

Although we fully support evidence-based decision making, we do not believe that the only valid evidence of a medication's utility comes from published, randomized, controlled, double-blind studies. A physician's clinical experience is important in evaluating appropriate use of a new intervention and wide consultation must be obtained—particularly among specialists familiar with the unique problems of the patients they treat. Whenever a dissenting consultative report is provided it must be noted in any evaluative summary.

An example of the selective use of information was the recent evaluation of zopiclone[3] by the Therapeutics Initiative. Following their moratorium, Pharmacare provided the revised indications for payment for this medication without any reasoned justification for their decision.

The process of appeal is not clear

A fair process provides an opportunity to present valid data that may inform decision-makers. There is insufficient clinical input into the evaluative process and often specialists are not consulted, even when a medication unique to their area is under review. We believe that, currently, specialists are underrepresented in the assessment process.

A fair process also requires the opportunity to challenge the decisions of the committee. Information used may be partially or totally inaccurate and, thereby, information disseminated from the process flawed. A fair and open process must incorporate an appeal mechanism and the process of that appeal, and its results, must be transparent.

In conclusion, it is our individual and collective intention to make our concerns widely known through our professional associations and with our political representatives. We welcome open discussion of our concerns with all parties and offer to participate with other stakeholders in a collaborative redesign of the current process.

—Dr Richard Bebb, Endocrinologist
Dr Claire Cameron, General practitioner
Dr Kevin Elwood, Respirologist
Dr Jonathan Fleming, Psychaitrist
Dr Jiri Frohlich, Medical biochemist
Dr Anthony Fung, Cardiologist
Dr Alice Klinkhoff, Rheumatologist
Dr Barry Koehler, Rheumatologist
Dr Graydon Meneilly, Geriatrician
Dr Tim Rowe, Obstetrician/gynecologist
Dr Derryck Smith, Psychiatrist
Dr John Wade, Rheumatologist

Richard A. Bebb, MD, ABIM, FRCPC, Claire Cameron, MD, Kevin Elwood, MD, Jiri Frohlich, MD, FRCPC, Anthony Fung, MD, Alice Klinkhoff, MD, Barry Koehler, MD, FRCPC, Graydon Meneilly, MD, Timothy C. Rowe, MBBS, FRCSC, FRCOG, Derryck H. Smith, MD, FRCPC, John Wade, MD, Jonathan Fleming, MB, FRCP. The drug review process in BC: A critique. BCMJ, Vol. 43, No. 2, March, 2001, Page(s) 86-87 - Premise.

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