Drugs Used to Treat Lung Cancer

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The Drug Approval Process

Quite often, we are asked how drugs are approved. In Canada, there is a systematic process carried out by several entities to determine and ensure the safety, efficacy and prices of drugs before they are available to the public.

Here is a brief summary:
  • The drug manufacturer submits a New Drug Submission (NDS) to Health Canada (1) for review and approval. This submission contains scientific data on the drug’s safety, efficacy and quality, results of preclinical and clinical trials, the therapeutic uses and side effects. This data is evaluated to determine the potential risks and benefits.
  • If Health Canada determines the benefits outweigh the risks, it officially approves the drug for sale, and the manufacturer receives a Notice of Compliance (NOC) or Notice of Conditional Compliance (NOC/c) and a Drug Identification Number (DIN). An NOC/c is authorization to market a drug with the condition that the manufacturer undertake additional studies to verify the clinical benefits.
  • At this point, physicians can prescribe the drug, however, it would be paid for out-of-pocket or through private health care plans.
  • Once approved, the Common Drug Review (CDR) (2) and the pan-Canadian Oncology Drug Review (pCODR) (2), administered by the Canadian Agency for Drugs and Technologies in Health (CADTH) will assess the data to determine the drugs eligibility for public reimbursement. In Qu├ębec, the National Institute of Excellence in Health and Social Services (INESSS) (2) carries out this role. Expert panels review the clinical evidence, cost-effectiveness, and patient and clinician perspectives. The new drug is also compared to existing drugs already on the market. With a positive recommendation, the next step is for drug programs to begin negotiating pricing with the manufacturer.
  • The pan-Canadian Pharmaceutical Alliance (pCPA) (3) conducts joint provincial, territorial and federal negotiations to help achieve better value for publicly funded drug programs and patients by combining the negotiating power of participating jurisdictions. This helps reduce duplication, and provides consistency in terms of decisions and cost effectiveness.
  • One jurisdiction will assume the lead on the negotiations with the manufacturer, and a letter of intent is signed when an agreement has been reached. It is then up to the participating jurisdictions to determine when to list it on their publicly funded formulary.
  • The Executive Officer of drug programs at each provincial Ministry of Health (4) receives this letter of intent and makes the final decision based on its committee’s recommendation, funding availability and the best interest of the public.
  • This drug approval process though extensive, aims to provide a thorough and objective evaluation of the submitted drugs, consistency in pricing, and ensure and improve access to clinically effective and cost-effective drug options
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