For MZ SR:

For GlaxoSmithKline Slovakia s.r.o. as authorised representative GlaxoSmithKline Trading Services Ltd., Ireland
Katarina Bodnárová- Governmental Affairs Manager
Jana Garai - Access Manager

The meeting took place at the request of GlaxoSmithKline's representative Slovakia s.r.o. Ms Katarína Bodnárová.

The meeting was opened by the Director General of the Department of Pharmacy and Drug Administration Ing. Jana Ivanova.

GlaxoSmithKline Slovakia Ltd.:
GlaxoSmithKline Slovakia s.r.o. asks MZ SR to change the special way reimbursement of medicinal products Nucala 2305D Nucala 100 mg solution for injection in pre-filled pen sol inj 1x1 ml/100 mg (piek.inj.napl.skl. in the pen) (hereinafter "Nucala') 2305Ds and Nucala 2307D Nucala 100 mg solution for injection in pre-filled syringe 1 x 1 ml/100 mg syringe (piek.inj.napl.skl.) (hereinafter "Nucala') In such a way that those medicines do not have a specific method of reimbursement, i.e. asks for a change in the status quo To be allowed self-administration.

This complaint is justified by the fact that Nucala 2305D a Nucala 2307D no obligation to administer medicinal products treating healthcare professionals, on the contrary, the medicinal product may self-administration or may be administered by a caregiver (which may not be by a healthcare professional).

At the meeting representatives of GlaxoSmithKline Slovakia s.r.o. they showed a pen that Nucala was given to which the patient could To administer the product alone as instructed by your treating physician at home environment.

MZ SR:
Director General of the Department of Pharmacy and Drug Policy Ing. Jana Ivanova stated that 7195B Nucala 100 mg powder for solution for injection According to § 16 § 1 of Law No 363/2011 Z.z. o scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods for on the basis of public health insurance and amending certain Acts as amended (hereinafter "the Act') listed categorized medicinal products from 09/2019, with a specific payment method –A-" Article 6 (11) of the Law, as proposed by the holder of the registration in the application for inclusion of the medicinal product in the list of categorised medicinal products.

Method of administration according to the SPC Nucala 100 mg powder for solution for injection: Nucala is for subcutaneous injection only and should be administered a health care professional.
For a medicinal product included in the list of categorised medicinal products, a specific method shall be established reimbursement of the medicinal product, if

  1. this is a medicinal product that must be administered to treating healthcare professionals,
  2. This is a medicinal product that contains toxic substances and may, in the event of normal disturbances of the packaging, health risks,
  3. it is a medicinal product which requires a specific storage method; or
  4. there is a risk of deterioration of the medicinal product taking into account the nature of the disease or hazardous handling.

On 31 January 2020, A1E applications were submitted for inclusion of medicinal products in the list. categorized medicinal products and the official price of the medicinal products 2305D Nucala and 2307D Nucala, which by its characteristics belong to any reference Groups included in the list of categorised medicinal products in this case R03DX09 mepolizumab SC 100 mg/ml.
Medicines 2305D Nucala and 2307D Nucala was according to § 16 §. 1 Act incorporated into List of categorised medicinal products from 1.6.2020 with a special method of reimbursement of –A" as A1E applications do not indicate a way of paying the medicine and is assigned to the reference group in which the product is already included the method of payment.

In this case, this is a specific case, as in the reference group the medicinal product enters without any specific means of reimbursement for the included medicinal product; method of payment - A.

Method of administration stated in the SPC Nucala 100 mg solution for injection in a syringe pre-filled pen, Nucala 100 mg solution for injection in pre-filled pen syringe:
Nucala in a pre-filled pen or pre-filled syringe should be used for subcutaneous injection only. The patient may To be administered by Nucala can be given by a caregiver if the healthcare professional decides it is appropriate and the patient or caregiver are trained in administration techniques injection.

Categorisation committee acting per roll dated 7.5.2020 Expert recommendation to the Minister for Health, published on the website of the Ministry of Health SR on 12.5.2020, on the complaint to change the method of reimbursement, on the grounds that The Ministry shall not initiate proceedings on its own initiative in this case, as a single reference group cannot be included in different ways credit transfers.

The Ministry also received a complaint from the President of Slovakia Mr doc. Dr Ivana Soloviča, CSc., who in the name of Slovak pneumology and phtizeology the company requests the abolition of the special payment method for medicines 2305D Nucala and 2307D Nucala while maintaining valid indication and prediction restrictions. If the currently applicable indication limits are met and granted the consent of the reviewer to the reimbursement of medicinal products, would change the method of reimbursement from Its prescription and dispensation was made possible by a public pharmacy.

Director General of the Department of Pharmacy and Drug Policy Ing. Jana Ivanova stated that, on the basis of the above, in accordance with current legislation.

The sitting was closed by the Director General of the Department of Pharmacy and Drug Administration Ing. Jana Ivanova.

She wrote:
Mgr. Judita Janek

Verified for GlaxoSmithKline Slovakia s.r.o.:
Katarina Bodnárová- Governmental Affairs Manager

It approved:
Ing. Jana Ivanova