November list of reimbursed drugs - summary of changes

REFUND NOTICE NO. 72 (NOVEMBER 1, 2023).

From the beginning of 2023, public funding will cover 145 new molecules and indications, including:

• 75 molecule - oncology indications,
• 70 molecule - non-oncology indications,
• 43 molecule - indications dedicated to rare diseases.

The reimbursement notice effective November 1, 2023 (No. 72) has been prepared in accordance with the new regulations effective November 1 regarding the determination of limit bases and the calculation of wholesale and retail margins. Compared to Announcement 71, it contains the following changes:

1. A total of 78 products or new indications were added to the list due to positive reimbursement decisions.
2. Reductions in official selling prices were introduced for 65 products (from PLN 0.01 to PLN 4,590.27).
3. Official selling prices were increased for 69 products (from PLN 0.51 to PLN 2,430.00).
4. For 994 items in the notice, the patient's co-payment will fall (from PLN 0.01 to PLN 452.70).
5. For the 2,886 items in the notice, the patient surcharge will increase (from PLN 0.01 to PLN 157.41).
6. Gross retail prices will be reduced for 70 products (from PLN 0.04 to PLN 197.18).
7. For 4215 products, gross retail prices will increase (from PLN 0.05 to PLN 91.92).
8. Due to the receipt of applications to shorten the term of reimbursement decisions, or the expiration of the term of reimbursement decisions or refusal of reimbursement for the next period, the announcement will not include 49 products or indications listed in the previous announcement.

INFORMATION ON THE LACK OF REIMBURSEMENT OF THE DRUGS FORXIGA, INVOKANA, FLUENZ TETRA AND XOFIGO SINCE NOVEMBER THIS YEAR

October 31, 2023, marks the expiration of the reimbursement and pricing decisions for two of the three currently reimbursed drugs in the oral anti-diabetes drug class - flosins:

• Forxiga, dapagliflozinum, 10 mg, film-coated tablets, 30 tablets, GTIN: 05909990975884, responsible party AstraZeneca AB,
• Invokana, canagliflozinum, 100 mg, film-coated tablets, 30 tablets, GTIN: 05909991096106, responsible party Janssen-Cilag International NV.

The responsible entity AstraZeneca AB has not submitted applications for the continuation of reimbursement for the next period of the above-mentioned drug Forxiga in all indications to date (diabetes, chronic heart failure, chronic kidney disease).

However, the application submitted by Janssen-Cilag International NV for continued reimbursement of the drug Invokana did not meet the conditions stipulated by the provisions of Article 13(2) 1 of the May 12, 2011 Law on Reimbursement of Drugs, Foodstuffs for Special Dietary Purposes and Medical Devices (Journal of Laws 2023, item 826, as amended, hereinafter the Reimbursement Law), which unambiguously indicates the maximum price of a drug applied for reimbursement if its market exclusivity period expires.

As a result, the Minister of Health has no legal option to continue reimbursing these drugs from November 1, 2023.

The Minister of Health informs that the decisions not to adjust the financial conditions to the current legislation and, consequently, not to continue reimbursing the drugs in question are individual decisions of AstraZeneca AB and Janssen-Cilag International NV resulting from the marketing strategy of these concerns.

These drugs will be eligible for reimbursement again when the responsible entities submit applications that meet the requirements of the Reimbursement Act, as notified by the Minister of Health. The ongoing reimbursement proceedings for the drugs Forxiga and Invokana, initiated as a result of the submission of the applications mentioned above, are currently at an advanced stage of proceedings.

At the same time, the Minister of Health would like to emphasize that the third drug in the phlozin group, i.e. Jardiance, coated tabl., 10 mg, Empagliflozinum, 28 pcs. financed for the following indications, will continue to be reimbursed:

• Type 2 diabetes mellitus in patients treated with at least two hypoglycemic drugs, with HbA1c ≥ 7.5% and very high cardiovascular risk defined as: 1) confirmed cardiovascular disease, or 2) damage to other organs manifested by: proteinuria or left ventricular hypertrophy or retinopathy, or 3) the presence of 3 or more major risk factors among those listed below:
  • Age ≥ 55 years for men, ≥60 years for women,
  • dyslipidemia,
  • hypertension,
  • smoking,
  • obesity,
• Chronic heart failure in adult patients with reduced left ventricular ejection fraction (LVEF≤40%) and persistent NYHA class II-IV disease despite therapy based on ACEi (or ARB/ARNi) and beta-blockers and, if indicated, mineralocorticoid receptor antagonists.

Fluenz Tetra vaccine in the form of an intranasal spray, previously reimbursed for the prevention of influenza in children aged from completed 24 months to completed 60 months and the prevention of influenza in children and adolescents aged from completed 60 months to completed 18 years, will no longer be publicly funded as of November 1, 2023. October 31, 2023 marks the expiration of the reimbursement decision and the setting of the official selling price, however, the responsible entity AstraZeneca AB, as in the aforementioned case, has not submitted applications for the continuation of reimbursement for the next decision period for Fluenz Tetra vaccine.

On October 31, 2023, the reimbursement coverage and official sales price decision for the drugXofigo, Radium dichloridum Ra223, Solution for injection, 1100 kBq/mL, 1 vial, 0.6 ml, GTIN: 05908229300176 under the drug program B.56. TREATMENT OF PATIENTS WITH CROP Tumor (ICD-10: C61) expires. Bayer sp. z o.o. has decided not to continue reimbursement of the aforementioned product as of November 1, 2023 under the conditions required by the Act on Reimbursement of Medicines, Foodstuffs for Special Nutritional Purposes and Medical Devices (Journal of Laws of 2023, item 826, as amended).

The responsible entity has submitted an application to the President of the National Health Fund to finance the drug Xofigo - as a continuation of treatment for patients who have started therapy with the drug Xofigo in the drug program B.56. TREATMENT OF PATIENTS WITH CROP Tumor Cancer (ICD-10: C61) under the rules described in Article 37b of the Reimbursement Act.

The Minister of Health informs that the decision not to continue reimbursement is an autonomous decision of Bayer sp. z o.o., and the Xofigo product will be eligible for reimbursement again, provided the company submits an appropriate application that meets the conditions described in the Reimbursement Law.

INFORMATION REGARDING THE ABSENCE OF TOUJEO AND ENSTILAR DRUGS ON THE LIST OF FREE MEDICINES FOR CHILDREN AND ADOLESCENTS UP TO 18 YEARS OF AGE

As of November 1, 2023, the list of free medicines for children and adolescents up to the age of 18 - Appendix D1 to the Health Minister's announcement on reimbursable medicines, foodstuffs for special nutritional purposes and medical devices - will lack the medicines Toujeo and Enstilar. The absence of the said medicinal products from the 18- list is a direct result of the scopes of reimbursement indications, which in the case of the drugs Toujeo and Enstilar apply only to adult patients:

• The reimbursement indication for the drug Toujeo: Type I diabetes mellitus in adults; Type 2 diabetes mellitus in adults patients who have been treated with NPH insulin for at least 6 months and with HbA1c ≥8%, and Type 2 diabetes in adults patients who have been treated with NPH insulin for at least 6 months and with documented recurrent episodes of severe or nocturnal hypoglycemia, and diabetes in adults with a known cause (as defined by the WHO),
• Enstilar's reimbursement indication: topical treatment of psoriasis vulgaris in adults.

Due to the lack of reimbursement in the pediatric population, these medicinal products will not be on the list of free drugs for children and adolescents as of November 1 this year.

INFORMATION ON THE EARLY ACCESS PROGRAM FOR TRASTUZUMAB DERUKSTEKAN TREATMENT

According to an announcement from the Ministry of Health, a bridging Early Access Program funded by AstraZeneca to accelerate therapy with the drug trastuzumab derukstekan for patients with HER2-positive metastatic breast cancer has been launched from September 18 to October 31, 2023. The program is open to all patients who meet the eligibility criteria for the B.9.FM drug program - for second-, third- or fourth-line treatment for inoperable or advanced HER2-positive breast cancer. Starting November 1, 2023. all patients meeting the criteria and enrolled in the Early Access Program from Sept. 18 to Oct. 31, under the provision "In addition, patients requiring continued treatment are also eligible for the drug program for the treatment of metastatic, HER2-positive breast cancer , who have been treated with active substances financed in the drug program under another means of financing therapy, except for ongoing clinical trials of these drugs, provided that they met the eligibility criteria for the drug program at the time they began treatment," will be able to continue therapy with trastuzumab derukstekan under drug program B.9.FM - TREATMENT OF PATIENTS WITH BREAST CANCER (ICD-10: C50).

Source: MZ