Drug Approval Updates and News

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    • #23551

      Great news today for adjuvant therapy in Canada. Dabrafenib (Tafinlar) + trametinib (Mekinist) revived a positive recommendation from pCODR, (the pan-Canadian Oncology Drug Review), for the adjuvant treatment of patients with stage IIIA (limited to lymph node metastases of > 1 mm) to stage IIID (8th edition of the American Joint Committee on Cancer [AJCC] staging system) BRAF-mutated (all BRAF V600 mutations) cutaneous melanoma. MNC is hopeful that price negotiations between provinces

      For full detials from pCODR please visit https://mailchi.mp/cadth.ca/cadth-pcodr-expert-review-committee-initial-recommendations-issued-pt?e=88c693f030

    • #23557
      bethhartebethharte
      Participant

      That’s great news!!

    • #29089

      ADJUVANT THERAPY APPROVED IN BC
      BC has approved adjuvant nivolumab for stage III melanoma as of Nov 1 and indication is for every 2 or 4 weeks as per patient choice or physician recommendation

      BC Cancer Patient Hand Out View Now
      BC Cancer Protocol Summary

    • #32880
      bethhartebethharte
      Participant

      I was speaking with a resident on my oncologist’s service who informed me that as of January 1st 2020 compassionate care delivery of Nivolumab for adjuvant treatment will no longer be offered to new patients. Is there any movement in Ontario to offer a program for those not covered by private insurance?

    • #32889
      Annette CyrAnnette Cyr
      Participant

      Hi Beth – sorry for the late reply. You are correct that the availability of both the Nivolumab and the Pembrolizumab through the compassionate access programs from the respective pharmaceutical companies will not be available as of January (end of Jan for the latter). Price negotiations for both adjuvant therapies have concluded, but in most provinces, the provincial governments are dragging their heals on listing the therapies. If you have private insurance, it may be covered, but for those patients without private coverage, they may be caught in middle without access to adjuvant therapy without provincial coverage. We will be reaching out to raise the issue this quickly. for those currently on treatment or enrolled, treatment will continue without interruption. Thanks for raising it and hoping you are doing well.

    • #33319

      Great news for Ontario – Cancer Care Ontario has a New Drug Funding Program effective January 29, 2020 – for Nivolumab – Adjuvant treatment for completely resected stage III or IV melanoma

      for information on the program click here

    • #36399

      A big week for Adjuvant therapy funding approvals!
      New Brunswick approved Nivolumab (Opdivo) for the adjuvant treatment of adult patients with completely resected stage IIIA (with lymph node metastases greater than 1mm) IIIB, IIIC, IIID and stage IV melanoma, based on the 8th edition of the American Joint Committee on Cancer melanoma staging system. Disease must be completed resected including in-transit metastases; however, presence of regional lymph nodes with micrometastases after sentinel node biopsy alone is allowed. 

      Alberta has listed Dabrafenib (Tafinlar) + trametinib (Mekinist)  for Adjuvant Treatment of Stage III BRAF-Mutated, Fully Resected Melanoma” on the Alberta Health Services Outpatient Cancer Drug Benefit Program effective April 10, 2020.
      Alberta Health Services Criteria and Listing Details

    • #36504

      Yukon has approved funding for Adjuvant therapy.

      The Yukon has listed dabrafenib (Tafinlar) + trametinib (Mekinist) for Adjuvant Treatment of Stage III-IV BRAF-Mutated, Fully Resected Melanoma” under their “ PEB programs” (Yukon Pharmacare Plan, Extended Health Care Benefits program, Chronic Disease and Disability program and the Children’s Drug and Optical program) effective April 15, 2020

      Please note that the Yukon follows the BC Cancer Drug Benefit List /Systemic Therapy Program guidelines for treatment and utilizes the CAP process, however do their own contracting and have a separate, unique reimbursement system.

      Eligibility criteria:

      Cutaneous melanoma stage IIIA to IV NED (AJCC 8th edition).
      Disease metastasized to the regional nodes (if stage IIIA and only one node involved then metastatic deposit > 1 mm), in-transit metastases or distant metastases must be completely surgically resected.
      Brain metastases must be completely resected (or definitively treated with stereotactic radiation)
      BRAF mutation (all BRAF V600 mutations)
      Adequate baseline hematological, renal and liver functions
      A Compassionate Access Program (CAP) approval is required prior to the initiation of treatment (please refer to https://cap.phsa.ca/).

      Additionally:

      Patients can receive one year of either adjuvant nivolumab OR combination dabrafenib/trametinib.
      Patients with BRAF mutated melanoma who are unable to tolerate up to a 3-month trial of combination dabrafenib/trametinib due to toxicities can apply for adjuvant nivolumab and complete a total of one year of therapy.
      A switch to combination cobimetinib/vemurafenib is not funded.
      May have subsequent BRAF/MEK inhibitors if relapse > 6 months after end of USMAJDT
      More details can be found on the below links:

      Use Protocol:

      http://www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Melanoma/USMAJDT_Protocol.pdf

      Preprinted Order:

      http://www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Melanoma/USMAJDT_PPPO.pdf

      Patient Handout:

      http://www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Melanoma/USMAJDT_Handout.pdf

      BCC Monograph:

      http://www.bccancer.bc.ca/drug-database-site/Drug Index/Trametinib_monograph.pdf

      http://www.bccancer.bc.ca/drug-database-site/Drug Index/Dabrafenib_monograph.pdf

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