What does the draft May reimbursement list change?

APTIC MARKET

According to the draft announcement, 19 packages of medicines, special dietary supplements and medical devices will be withdrawn from pharmacy reimbursement, and 12 others will be included. Funding will be given to 1 combination of active substances:

• Telmisartanum + Indapamidum - Ylpio product from PRO.MED.CS Praha a.s. (date of first marketing authorization: August 30, 2021) in all registered indications as of the date of the decision.

At the same time, according to the draft notice, no active substance will lose funding.

The draft does not provide for an expansion or narrowing of the scope of financing for active substances already on the reimbursement list,

According to the draft announcement, the first equivalent under 1 active substance will be introduced under pharmacy reimbursement:

• Elimination milk replac er diet - within group 217.6, Elimination milk replacer diet - elemental mix for infants and children, the product Blemil plus Elemental from Laboratorios Ordesa Sl with a reduction in the official selling price of -27% compared to the price of the only product reimbursed to date (the product Nutramigen PURAMINO from Mead Johnson & Company, LLC).

The level of the patient's co-payment will decrease for 309 packages of medicines, special foodstuffs and medical devices. Changes exceeding PLN 10 will apply to 7 of them. The largest reductions will apply to the following products: Firazyr(Icatibantum, solution for injection, 10 mg/ml, 1 amp.shots, 3 ml each) - by PLN 196.80, Toujeo(Insulinum glarginum, solution for injection in an injector, 300 IU/ml, 10 SoloStar injectors, 1.5 ml each) - by PLN 41.31, and Abasaglar(Insulinum glarginum, solution for injection in a cartridge, 100 IU/ml, 10 cartridges, 3 ml each) - by PLN 27.54. In the case of Firazyr, the reduction is due to a reduction in the official sales price of this drug, while the

For Toujeo and Abasaglar products, the reductions are due to changes in the basis of the limit in group 14.3, Pancreatic hormones - long-acting insulin analogs. As of May 2023, the limit in this group will be set by the product Abasaglar(Insulinum glarginum, solution for injection in a cartridge, 100 IU/mL, 10 cartridges of 3 mL).

In turn, the increase in patient surcharges will affect 325 packages. For 32 of them, the price increase will exceed PLN 10. The largest increases will apply to the following products: Novo-Helisen Depot( house dust mite allergenextracts, concentration 3 - 5000 TU/ml or 5000 PNU/ml, 2 vials. 4.5 ml each) - by 452.70 zł, Icatibant Accord(Icatibantum, solution for injection, 10 mg/ml, 1 amp.shots, 3 ml each) - by PLN 152.47, and Trevicta(Paliperidonum, extended-release suspension for injection, 525 mg, 1 amp.-shot. 2.625ml + 2 needles) - by PLN 84.89. These increases are due to changes in the limit bases in groups 214.1, Household dust allergens, 241.2, Drugs used in hereditary angioedema - icatibant, and 178.14, Antipsychotic drugs - paliperidone for parenteral use - extended-release forms. From May 2023, the limits in these groups will be set by Novo-Helisen Depot( allergenicextracts of house dust mites, concentration: 1 - 50 TU/ml or 50 NSAIDs/ml; 2 - 500 TU/ml or 500 NSAIDs/ml; 3 - 5000 TU/ml or 5000 NSAIDs/ml, 3 vials of 4.5 ml), Firazyr(Icatibantum, solution for injection, 10 mg/ml, 1 amp.-shot, 3 ml each) and Paliperidone Teva(Paliperidonum, extended-release suspension for injection, 75 mg, 1 amp.-shot. 0.75 ml).

Official selling prices will be reduced for 15 packages of medicines, special dietary foods and medical devices, by an average of 10.1%. All reductions exceed PLN 10, the largest of which will apply to products containing the active substance Lanreotidum: Somatuline Autogel (solution for injection, 120 mg, 1 amp.-shot, 0.5 ml each) - by PLN 361.29, Somatuline Autogel (solution for injection, 90 mg, 1 amp.-shot, 0.5 ml each) - by PLN 270.97, and the product Firazyr(Icatibantum, solution for injection, 10 mg/ml, 1 amp.-shot, 3 ml each) - by PLN 332.64.

At the same time, official selling prices will be raised for 45 packages of products on the lists, by an average of 13.4%. Changes exceeding PLN 10 will affect 5 of them. The largest increases apply to products: Milupa PKU 2 secunda( Eliminationdiet in phenylketonuria, powder, 500 g) - by 37.56 PLN, Ryzodeg(Insulinum degludecum + Insulinum aspartum, solution for injection, 100 IU/mL, 5 cartridges of 3 ml Penfill) - by 36.39 PLN, and Milupa PKU 2 prima, powder( Eliminationdiet in phenylketonuria, powder, 500 g) - by 30.80 PLN.

75+

The "S" list will include 1 new active substance combination(Telmisartanum + Indapamidum), no substance will lose funding. The "S" list will include 4 new packages, while withdrawing 14 other packages.

PREGNANCY

The list of free medicines for pregnant women will include 3 new drug packages, while none will be removed from the list. The list will not be expanded by any active substance, nor will any substance lose funding.

HOSPITAL MARKET

According to the draft announcement, 4 new active substances will appear in drug programs:

• Azacitidine - Bristol-Myers Squibb Pharma EEIG's Azacitidine product (date of first marketing authorization: June 17, 2021) available under the existing drug program B.114 Treatment of patients with acute myeloid leukemia (ICD-10: C92.0);
• Filgotinibum - a product of Jyseleca from Gilead Sciences Ireland UC (date of first marketing authorization: September 24, 2020) available under the existing drug program B.55 Treatment of patients with ulcerative colitis (UC) (ICD-10: K51);
• Rurioctocogum alfa pegolum, an Adynovi product from Baxalta Innovations GmbH (date of first marketing authorization: January 8, 2018) available under the existing drug program B.15 Prevention of bleeding in children with hemophilia A and B (ICD-10: D66, D67);
• Tafasitamabum, a Minjuvi product from Incyte Biosciences Distribution B.V. (date of first marketing authorization: August 26, 2021) available under the existing drug program B.12.FM Treatment of patients with B-cell lymphoma (ICD-10: C82, C83, C85).

According to the draft announcement, 2 active substances will lose funding:

• Imatinibum - so far available under drug program B.3 Treatment of gastrointestinal lining tumors (GIST) (ICD-10 C15, C16, C17, C18, C20, C48) - this active substance, however, as of May 1, 2023, will be available in the chemotherapy catalog, among other indications previously reimbursed under catalog B;
• Sunitinibum - so far available under drug programs B.3 Treatment of gastrointestinal lining tumors (GIST) (ICD-10 C15, C16, C17, C18, C20, C48), B.8 Treatment of soft tissue sarcomas (ICD-10 C48, C49), B.10 Treatment of patients with renal cell carcinoma (ICD-10: C64) and B.53 Treatment of highly differentiated neuroendocrine tumor of the pancreas (ICD-10 C25.4) - this active substance, however, will be available in the chemotherapy catalog as of May 1, 2023, for indications previously reimbursed under catalog B.

According to the draft announcement, the first equivalent under the drug programs will be introduced under 2 active substances:

• Cabazitaxelum - Eleber's product, with a reduction in the official selling price of -55% compared to the price of the only previously reimbursed drug with this active substance (EVER Valinject GmbH's Cabazitaxel Ever Pharma product);
• Ranibizumab, a product of Ximluci, with a reduction in the official selling price of -35% compared to the price of the only previously reimbursed drug with this active substance (the Lucentis product of Novartis Europharm Limited).

The project envisages expanding the scope of financing to include new drug programs for 3 already reimbursed active substances:

• Cemiplimabum, a product of Regeneron Ireland Designated Activity Company's Libtayo, included in the existing drug program B.88 Treatment of patients with basal cell carcinoma of the skin (ICD-10: C44);
• Ibrutinibum - Imbruvica from Janssen-Cilag International NV included in the existing drug program B.12.FM Treatment of patients with B-cell lymphoma (ICD-10: C82, C83, C85);
• Ozanimodum, a Zeposia product from Bristol-Myers Squibb Pharma EEIG of the existing drug program B.55Treatment of patients with ulcerative colitis (UC)(ICD-10:K51).

The draft includes narrowing the scope of funding for 2 already reimbursed active substances:

• Everolimusum - the products Afinitor, Everolimus Accord, Everolimus Stada and Everolimus Vipharm will no longer be available under drug programs B.10 Treatment of patients with renal cell carcinoma (ICD-10: C64) and B.53 Treatment of highly differentiated neuroendocrine tumor of the pancreas (ICD-10 C25.4) as of May 2023, with these products available under the chemotherapy catalog for a similar range of indications. Everolimusum (product Votubia) will remain available under the drug program catalog in program B.89 Treatment with everolimus of tuberous sclerosis patients with surgically ineligible subepithelial giant cell tumors (SEGA) (ICD-10 Q85.1);
• Sorafenibum - the products Sorafenib Teva, Sorafenib G.L., Sorafenib Pharmascience, Sorafenib Sandoz, Sorafenib Stada, and Sorafenib Zentiva as of May 2023 will no longer be available under drug programs B.3 Treatment of Gastrointestinal Stem Tumors (GIST) (ICD-10 C15, C16, C17, C18, C20, C48), B.5 Treatment of patients with hepatocellular carcinoma (ICD-10: C22.0), and B.10 Treatment of patients with renal cell carcinoma (ICD-10: C64), with these products to be available within the chemotherapy catalog for a similar range of indications. Sorafenibum (product Nexavar) will remain available within the drug program catalog in program B.119 Treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/alveolar/oxophilic - from Hürthle cells) thyroid cancer refractory to radioactive iodine treatment (ICD-10 C 73).

One product currently reimbursed under drug programs is losing market exclusivity:

• HyQvia - Immunoglobulinum humanum normale, a product from Baxalta Innovations GmbH (date of first marketing authorization: May 16, 2013) with a 25% reduction in the official price and continued reimbursement for another three years.

A total of 60 drug packages will be removed from the drug programs according to the draft announcement, while 25 new ones will be introduced.

The official selling prices of 14 packages of drugs used in drug programs will be reduced, the average reduction for these products is 27.5%. The draft announcement does not provide for an increase in the selling price of any package of a drug used in drug programs.

Within the chemotherapy catalog, according to the draft announcement, there will be 3 new active substances:

• Everolimusum - The products Afinitor, Everolimus Accord, Everolimus Stada and Everolimus Vipharm, previously available under drug programs B.10 Treatment of patients with renal cell carcinoma (ICD-10: C64) and B.53 Treatment of highly differentiated neuroendocrine tumor of the pancreas (ICD-10 C25.4), will from May 1, 2023 be available in identical indications under the chemotherapy catalog;
• Sorafenibum - the products Sorafenib Teva, Sorafenib G.L., Sorafenib Pharmascience, Sorafenib Sandoz, Sorafenib Stada, and Sorafenib Zentiva, so far available under drug programs B.3 Treatment of gastrointestinal lining tumors (GIST) (ICD-10 C15, C16, C17, C18, C20, C48), B.5 Treatment of patients with hepatocellular carcinoma (ICD-10: C22.0), and B.10 Treatment of patients with renal cell carcinoma (ICD-10: C64), will be available in identical indications within the chemotherapy catalog starting May 1, 2023.
• Sunitinibum - products Klertis, Suganet, Sunitinib Accord, Sunitinib Glenmark, Sunitinib Krka, Sunitinib Pharmascience, Sunitinib Sandoz, Sunitinib Stada, Sunitinib Teva, Sunitinib Zentiva, Sunitinib Mylan and Sutent, so far available under drug programs B.3 Treatment of gastrointestinal lining tumors (GIST) (ICD-10 C15, C16, C17, C18, C20, C48), B.8 Treatment of soft tissue sarcomas (ICD-10 C48, C49), B.10 Treatment of patients with renal cell carcinoma (ICD-10: C64), and B.53 Treatment of highly differentiated neuroendocrine tumor of the pancreas (ICD-10 C25.4), will be available in identical indications under the chemotherapy catalog starting May 1, 2023.

According to the draft, no substance will lose funding.

The draft also provides for the expansion of the finances of 2 previously reimbursed active substances:

• Imatinibum - Imatinib Accord, Meaxin and Nibix will be reimbursed for the indication of gastrointestinal lining tumors (GIST) from May 2023, these products were previously available for this indication under the drug program catalog;
• Lenalidomide - Kleder products, Lenalidomide Accord, Lenalidomide Aurovitas, Lenalidomide Glenmark, Lenalidomide Grindeks, Lenalidomide Krka, Lenalidomide Medical Valley, Lenalidomide Mylan, Lenalidomide Pharmascience, Lenalidomide Sandoz, Lenalidomide Teva, Lenalidomide Zentiva, Linorion, Polalid and Revlimid will be reimbursed for the indications of nodular non-Hodgkin's lymphoma, diffuse non-Hodgkin's lymphoma and B-cell lymphoma as of May 2023.

The draft does not provide for a narrowing of reimbursement indications.

A total of 6 packages of drugs will be removed from the chemotherapy catalog according to the draft announcement, while it will be expanded by 56 packages. The official selling price of 8 packages of drugs used in the chemotherapy catalog will be reduced, on average, by 26.0%. The draft announcement does not provide for increases in the selling price of drugs used in the chemotherapy catalog.

Source: IQVIA