Clinical Nutrition Products

 

HSE Clinical Nutritional Products Group

The HSE Primary Care Reimbursement Service has published the Reimbursement List of Clinical Nutritional Products Guidelines for Manufacturers/Distributors under the GMS and Community Drug Schemes.

DownloadHSE PCRS Reimbursement List of Clinical Nutritional Products Guidelines for Manufacturers/Distributors

The HSE will accept applications for products which satisfy the published criteria at either the;

  • UK adjusted price (at 12 month average exchange rate), or
  • Average of the lowest three European countries submitted, or
  • Price proposed to the HSE

for the lowest price agreed for any product included in the relevant Category/Sub Categories, having regard for differences in sizes, presentation etc. The HSE will require independent validation of the European prices submitted which must accompany the application documentation.

As previously published, there are a number of categories which include broadly similar products. It is our intention to operate a ‘single price’ mechanism for these broadly similar products. These categories may be subject to change as new applications are processed in line with emerging clinical practice.

As with Drugs and Medicines, the HSE is prepared to reimburse a ‘fair price’ for true innovation but does not intend to pay a premium for a product which cannot demonstrate that such innovation improves patient outcomes.

Notes for applicants wishing to make nutritional product submissions for HSE reimbursement

Applicants wishing to make a Clinical Nutritional Product application for reimbursement to the HSE should note the following:

  • When making an application, the application form must be downloaded in its entirety and used as a template with the statements supporting an application appearing under the relevant heading/paragraph
  • Applicants must respond to each and every requirement as indicated and provide a statement that the requirement either can or cannot be met along with brief supporting evidence.
  • Applicants must conform to this format and layout
  • All information must be provided in English
  • Evidence that the clinical nutritional product has been notified to the FSAI for Type 1 and Type 2 applications.

Applications which do not conform to the above requirements will not be accepted. No other information other than that which has been requested should be attached.

Please refer to the Guidelines and the appendices contained within for further information about any of the above.

Application Forms

There are three types of Application Forms for products:

Type 1- New Product Application Form (New formulations to be added to HSE Reimbursement List)

Type 2- Product Application Form (Formulations which are broadly similar in composition to existing products already on the market and which could be considered to be suitable alternatives)

Type 3- Minor Change Application Form (Existing products to which minor changes are proposed)

Submitting to the HSE

Correspondence must be conducted via email. This is to ensure transparency and a clear audit trail. Application forms must be submitted to the following:

reimbursement.applications@hse.ie