Biosimilars, Medical Cannibis, National Pharmacare and More: Executive Director Update

Denis Morrice

On the Biosimilar Front

The pan-Canadian Pharmaceutical Alliance (pCPA) has created a guidance document, “Biologics Policy Directions and pCPA Negotiations” and is holding consultation sessions with various stakeholders. Consideration is being given to negotiations for Biosimilars to begin in parallel with the HTA process: tiered listings may be implemented in therapeutic areas where appropriate; switching of patients from reference biologic molecule to a biosimilar may be implemented.

Cancer Care Ontario is supporting the pCPA in launching a cancer-specific strategy to drive the appropriate use and uptake of oncology biosimilars in Canada.

The European Society for Medical Oncology noted the importance of education of all stakeholders, good evidence, and sustainability and impact on healthcare budgets.

The ORA has added a Q&A section to its biosimilar statement on their website at this link: updated position statement. It is important to note that ORA is staying on top of any new evidence, and it is good to see that ORA has been out front on this issue.

On the Cannabis Front …

The Canadian Medical Association (CMA) does not want to be the gatekeeper on Cannabis. Their concern is rooted in the lack of research and pharmaceutical standards re: dosage, potency, risk, and potential complications.

Pharmacists have noted that they are medication experts and are equipped to provide clinical advice to patients and appropriate oversight in the safe management and dispensing of medical cannabis.

Shoppers Drug Mart is now a licensed medical marijuana producer.

The OBRI through CAC and PAC with the support of MedReleaf are designing research questions to help fill the information gap.

The GI Society prepared a video narrated by Dr. James Gray of VGH – worth viewing and sharing with patients. https://www.badgut.org

On the EAP/OHIP+/OPDP Front …

The ORA has presented some 14 items to be addressed during October meetings including policy changes and the TFA situation at OHIP+; EAP approval times and drugs being moved to LU codes; treatment for severe Reynaud’s and Digital Ulcers; Giant Cell Arteritis; Progressive Systemic Sclerosis; form for Vasculitis and more.

A special thank you is owed to Dr. Janet Pope who submitted numerous documents to support treatment for Interstitial Lung Disease along with suggested criteria. The OPDP now wants a full blown submission similar to that required by pharmaceutical companies (that have full time submission and regulatory staff). We believe a medical association and specialists that deal with patients on a day to day basis should be treated quite differently.

On the National Pharmaceutical Front …

The Advisory Council on the Implementation of National Pharmacare are 80% through their stakeholder consultations. A preliminary report is due by Dec 31, 2018 and the final report is scheduled for April 2019. With today’s patchwork of 100 public and 100,000 private insurance plans it is hoped that positive changes will take place. The ORA does its best to have input at the consultations being held by Health Canada, CADTH, PMPRB, pCPA and the Advisory Council.

A reality check: Dr. Purvis and her committee submitted a request to the pCPA for a panCanadian approval and renewal criteria of biologics for RA endorsed by CRA, TAS, CAPA, and CLHIA. Preliminary response: some provinces need to give it more thought. So, if provincial drug program managers can’t agree to move on the ORA request how will they ever agree to a National Pharmacare program?? We are going at it a second time.

On the CADTH Front …

Some positive news: CADTH and INNESS have agreed to jointly engage with clinical specialists to strengthen the current pharmaceutical review process and reduce duplication.

Denis Morrice,

Executive Director, ORA