GVS assessment of hydrocortisone (Alkindi®) for the treatment of adrenal insufficiency
The National Health Care Institute has completed its assessment whether hydrocortisone (Alkindi®) can be included in the Medication Reimbursement System (GVS). The marketing authorisation holder for Alkindi® has submitted an application for the inclusion of this medicinal product on List 1B of the Health Insurance Regulation. Based on the applicable criteria, Alkindi® is not interchangeable with the other oral hydrocortisone preparations included in the GVS as substitution therapy for adrenal inefficiency because it is a form of administration specifically aimed at children. It is therefore eligible for inclusion on List 1B. Patients and practitioners expressed their care however, about substitution of a (re-delivered) pharmacy preparation by Alkindi®. For some of the patients where the prescriber is of the opinion that the substitution of the pharmacy preparation by Alkindi® poses a risk to the correct use, the continued availability of the pharmacy preparation could be beneficial and thus prevent possible medication errors.
Registered indication
Alkindi® contains hydrocortisone. It is indicated for substitution therapy for adrenal insufficiency in infants, children and adolescents (from birth to < 18 years). Each capsule contains 0.5, 1, 2 or 5 mg hydrocortisone. The dosage must be adjusted to the response of the individual patient. The lowest possible dosage should be used.
Adrenal insufficiency is a condition in which the adrenal glands produce no or insufficient amounts of corticosteroid hormones. The treatment consists of substitution of deficiencies, crisis management and education/coaching. The shortage of cortisol is usually substituted with hydrocortisone, which is most similar to the natural cortisol. The desirable and undesirable effects of hydrocortisone depend on the correct adjustment of the dosage. The dosage must be adjusted to the response of the individual patient.
The pharmacy preparations that are now used for children have been developed in collaboration with representatives of patients and practitioners. These products are available in paediatric-appropriate forms of administration, using tablets in different colours.
Assessment
Alkindi® is not interchangeable with the other medicinal products in the GVS on the basis of the criteria currently in force. There is a difference in age category compared to the hydrocortisone preparations included in cluster 0H02ABC0V. Alkindi® has a form of administration specifically developed for children. Based on the above, Alkindi® cannot be placed on List 1A. It should be reviewed whether Alkindi® is eligible for inclusion on List 1B.
Consultation
Parties indicate that:
- Alkindi® has no clear added value for the Dutch market compared with the available pharmacy preparations, and that it does entail risks.
- For the proper administration of Alkindi®, the registration text describes detailed instructions that must be followed to avoid medication errors. Parties expects that a complicated intake will not promote patient compliance. The use of Alkindi® is a clear risk because this requires more from the children to use the medicinal product correctly.
- Finally, health insurers also point out the importance of keeping the pharmacy preparation available.
The advice of the National Health Care Institute
Based on the applicable criteria, Alkindi® is not interchangeable with the other oral hydrocortisone preparations included in the GVS as substitution therapy for adrenal inefficiency because it is a form of administration specifically aimed at children. It is therefore eligible for inclusion on List 1B.
The National Health Care Institute brings this to the attention of the minister. Patients and practitioners expressed their care about substitution of a (re-delivered) pharmacy preparation by Alkindi®. For some of the patients where the prescriber is of the opinion that the substitution of the pharmacy preparation by Alkindi® poses a risk to the correct use, the continued availability of the pharmacy preparation could be beneficial and thus prevent possible medication errors.