In Europe, Advocates Emphasize Role of Patient Voice

Just consider Arthritis Ireland.  As highlighted during a recent Global Alliance for Patient Access webinar, the group saw patient input make a difference during the country’s experience with access to lidocaine patches.  The medication numbs the skin to help patients manage pain.

Arthritis Ireland explained that, in 2016, about 25,000 patients were receiving the pain patches, reimbursed through the Community Drugs Scheme.  Then the Medicine Management Programme published a prescribing and cost-guidance report. The document highlighted gaps in clinical data on the lidocaine patches’ use.  The programme recommended restricting access to the drug, triggering changes to reimbursement.

The new arrangement was not conducive to patient access.  Patients with postherpetic neuralgia, which causes patients a burning pain due to affected nerve fibres, had to register and be granted approval for the drug’s use.  Patients with other types of pain, considered “unlicensed indications” of the lidocaine patches, had to complete an application process that lasted up to three days.

Disgruntled patients’ voices emerged, then slowly rose to a fever pitch.  In particular, a national broadcaster’s phone-in radio show fuelled outcry that soon became a media rollercoaster.  From there, the country’s politicians picked up on the issue.

The upper and lower houses of Parliament debated access to lidocaine patches. Chronic Pain Ireland obtained an interview with the head of the Medicine Management Programme. And the National Centre for Pharmacoeconomics began consulting with patient organisations.  The outcome: changes in protocol around the review process, improved access for patients and greater leeway in being able to argue for extenuating circumstances.

Biologics, Biosimilars & Treatment Switches

Webinar participants also underscored the importance of the patient voice in selecting among biologics and biosimilar treatment options.

• Gerardine Willemsen-de Mey described a study performed by the National Association ReumaZorg Nederland with 13 other organisations.  The groups examined the decision-making process between physician and patient, highlighting the fact that patients’ biologics or biosimilar may be changed every three to six months.  Willemsen-de Mey explained that near-constant change can cause patients to lose confidence in their medication and cease taking it as prescribed. Advocacy groups are asking insurance companies to stop making it difficult for patients to keep their original medicine.
• Jadranka Andreic of Remisija, Croatia provided a different perspective.  In Croatia, patients are required to give their consent for any medication switches.  The changes cannot be driven by economic reasons alone. Meanwhile, health care providers have autonomy to choose the biologic or biosimilar that’s best for their patient.
• A representative from the Portuguese League Against Rheumatism explained how biologics and biosimilars are approached in Portugal.  The National Committee for Therapeutic and Pharmacy guidance on biologics requires that any switch between biologic and biosimilar medications should have a minimum period of not less than six months to ensure traceability.  Any switching should be done with precaution and with attention to the indication for each drug.

The system is focused on the financial savings, and guidelines aim to facilitate switching stable patients to cut costs.  That said, the guidance encourages all physicians, pharmacists, and nurses involved in a switch to be informed about the process.  The decision to change should also be explained by the prescriber to the patient, providing all the necessary information.

In written comments to the National Committee for Therapeutic and Pharmacy, patients and advocates conveyed that additional data from switching studies of these therapies is still needed, as is continuing pharmacovigilance. Switching should remain a case-by-case clinical decision, patient advocates argue, made by the physician and patient on an individual basis supported by scientific evidence.

Regardless of individual countries’ policies and experiences, organisations participating in GAfPA’s webinar were unanimous on one critical point: the decision-making process for selecting or changing medications must remain with the doctor and the patient.