Bill 102 Update

DENIS MORRICE
Canadian Skin Patient Alliance

Helen Stevenson, director of Ontario’s Drug System Secretariat, provided a first-quarter update on the Transparent Drug System for Patients Act (Bill 102), since it came into effect on October 1, 2006.

Although the search for a permanent Ontario Drug Benefit Executive Officer continues, the Secretariat (which will eventually meld into the EO’s staff) has been busy preparing the terrain and has some early statistics to prove it. Since October 1, the ODB has added 23 new brand-name drugs and 26 generic drugs to the provincial formulary; 12 partnership agreements have been signed with drug manufacturers; and, as a result, five drugs have been given a conditional listing, thereby eliminating 40,000 Section 8 requests (about a quarter of all requests). All this information and much more will soon be publicly available through a dedicated phone service and on a new web page.

Rapid Review
The new ODB rapid review process for breakthrough drugs is now operative. Three out of seven drugs submitted so far for rapid review are now being evaluated. The process allows the review to start before Health Canada issues a Notice of Compliance and sets a goal of announcing decisions within 30 days of the NOC. The plan is to allow the public to track the different stages a rapid-review (or any) submission must go through; however, it was noted that Health Canada doesn’t reveal which drugs it’s reviewing so there may be an unintended procedural conflict. ODB recommendations will be posted four to six weeks after the decision and will follow a standard format: background, highlights of the deliberation, rationale for the decision and where to find a new drug in the formulary (class/availability). The delay between reaching a decision and publicly announcing a decision is to allow manufacturers time to respond. Rx&D and a number of individual drug companies have been briefed on the rapid-reviewprocess and seem in agreement, according to the Secretariat. All recommendations since October 1, 2006, should be posted on the ODB website by the end of February 2007.

Committee to Evaluate Drugs (CED)
This all-important committee has been provided with tools to help guide its assessments, chief among them an algorithm to “clarify its thought processes.” Thus, for example, a breakthrough drug that generated many early access requests from physicians would be considered for conditional listing, whereas another breakthrough drug that had relatively fewer requests might be considered for exceptional access. The goal of such distinctions is to make the whole process more manageable and responsive. Section 8 will continue until all drugs currently in this obsolete category are addressed. There is also a provision to identify top-level Ontario specialists who would be officially authorized to prescribe breakthrough experimental drugs as part of a trial or through compassionate access.

So far, the partnerships signed with manufacturers are meant to support conditional and exceptional-access listings. Currently, the CED is conducting an in-depth review and update of prices on all 3400 products on the formulary and has de-listed 400 drugs that have been discontinued by their manufacturers. Two patient representatives will be appointed to the CED. Cost neutrality will be an accepted standard in decisions, which suggests that new listings might lead to de-listing of older drugs. All CED decisions have an automatic review, although it wasn’t clear whether such a review would be conducted by an external third party. Re-evaluation of a decision or renewal of formulary coverage would be predominantly based on new clinical evidence.

Generic Drugs
In response to the law’s price regulation of generic drugs, the industry claimed that some 200 drugs would no longer be viable from a business perspective if the price was pegged at half the corresponding brand-name price. After a thorough review of the 200 drugs, an exception was made for 60 (out of about 1500 generic drugs in total on the formulary), mainly because of safety concerns if they were de-listed. The Secretariat remained vague on whether the ODB price was the market price, noting that it was entirely a pharmacy’s decision whether it adopted a two-price model or not. For the time being, private plans appear to be paying the higher price or a higher dispensing fee.

Pricing
As a result of industry pressure on Dalton McGuinty, who manages the scientific innovation portfolio, the province’s long price freeze will likely undergo a moderate thaw in return for industry assurances on R&D investment. However, price increases will be based on “big picture” factors, not just cost-to-operator drivers. Lots of negotiation remains.

Pharmacy Council
The Council is trying to determine what type of professional services for patients should be remunerated, what would be the standards of practice (ie: separate area for client counseling) and what accountability would be required. Members represent a broad cross-section of different pharmacy practices (rural, urban, independent, chain, family health teams). It was suggested there should be a fee for assisting patients with paperwork for Trillium funding. The Secretariat confirmed that the $50-million dedicated fund for these new services is an annual budget item.

Interchangeability
The point was reiterated that the definitions in the legislation and regulations make it clear that therapeutic substitution is not permitted. The expanded definition of interchangeability, the Secretariat suggested, was to crackdown on the brand-name industry practice of “evergreening,” whereby changes in method of delivery (or other small changes) were used to prolong patent protection.

Common Drug Review
Although there are no plans to withdraw from the Common Drug Review, it’s pretty clear that a CED recommendation trumps a CDR recommendation. Also, the CED now has access to much the same Health Canada data as the CDR. Remaining in the CDR seems more a question of hedging a bet, since CDR reviews tend to be more in-depth and may come up with new data. Nevertheless, it would appear that in Ontario the CDR is becoming not only redundant but also irrelevant.

Citizens Council
Since there are bound to be many applications for this new council of 25-30 members, an apolitical nominating committee under the aegis of the Public Appointments Secretariat will develop a short list for consideration by the Minister. Appointments are made through an Order in Council. The Citizens Council’s mandate is to debate issues and inform drug policy, with more emphasis on debate than on consensus. It was suggested that an ethicist (and other expert advisors) might prove valuable to council members. Members of patient advocacy groups and non-profit health organizations are eligible.

Transparency
As mentioned above, the Committee to Evaluate Drugs will be recruiting two patient representatives for three- to four-year terms. Patient and non-profit organizations will be approached for suitable candidates, who will then go through a formal review process by the government’s Public Appointments Secretariat. It was noted that the CED’s oncology sub-committee would also have patient representatives.

As of February 2007, visitors to ODB website should be able to track the process and status of a given drug evaluation up to the final recommendation, which will be posted after the Executive Officer’s approval. It was made clear that the CED review wasn’t a pharmaco-economic review and that the Executive Officer was responsible for the economic impact of a new drug. Brand-name and generic formularies will be published on the web monthly, along with an annual hard copy. The Executive Officer will publish progress reports, as well as an annual report separate from the ODB annual report.

Drug companies will have access to a “fairness review committee,” a small group outside the CED that would examine whether the CED process for a particular drug was impartial and properly executed. There was considerable debate about whether industry could audit the review, and it was suggested that a checklist of fairness criteria be developed that would simplify the review process. However, a direct appeal to the Executive Officer remains a final option, since the EO has the discretionary power to ignore a CED recommendation.

Brand-name drugs added to the ODB formulary since October 1, 2006

• Aclasta Solution (Paget’s disease)
• Actos (type 2 diabetes)
• Aranesp (cancer chemotherapy-related anemia)
• Avandia (type 2 diabetes)
• Caduet tablets (cardiovascular disease)
• Crestor (high cholesterol)
• Eprex (cancer chemotherapy-related anemia)
• Fosavance (osteoporosis)
• Fosamax (osteoporosis)
• Gleevec (chronic myeloid leukemia)
• Invirase (HIV/AIDS)
• Lipidil EZ tablets (high cholesterol)
• Myfortic (organ transplantation)
• Norprolac tablets (hormone disorder)
• Pariet (acid suppression)
• Sandostatin SC (cancer and other indications)
• Sandostatin LAR (cancer and other indications)
• Tobi (cystic fibrosis)
• Trelstar (prostate cancer)
• Videx EC (HIV/AIDS)
• Viread (HIV/AIDS)
• Xeloda (colorectal cancer and breast cancer)

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