Risperidone, powder for I.M. injection, 25 mg, 37.5 mg and 50 mg (modified release) with 2 mL diluent in pre-filled syringe, Risperdal Consta®, July 2005
Public Summary Document for Risperidone, powder for I.M. injection, 25 mg, 37.5 mg and 50 mg (modified release) with 2 mL diluent in pre-filled syringe, Risperdal Consta®, July 2005.
Page last updated: 11 November 2005
Product: Risperidone, powder for I.M. injection, 25 mg, 37.5 mg and 50 mg (modified release)
with 2 mL diluent in pre-filled syringe, Risperdal Consta®
Sponsor: Janssen-Cilag Pty Ltd
Date of PBAC Consideration: July 2005
1. Purpose of Application
This application sought Section 100 listing (Highly Specialised Drug) for risperidone long-acting intramuscular injection in addition to the current section 85 listing. (Highly Specialised Drugs (HSDs) are medicines for the treatment of chronic conditions, which, because of their clinical use or other special features, are restricted toprescribing through public and private hospitals which have appropriate specialist facilities.)
At the July 2004 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended a section 85, authority required listing of Risperdal Consta for the treatment of schizophrenia. (A Section 85 listing is for medicines prescribed through the community, not necessarily attached to a specialist facility. Section 85 listings appear in the white pages of the Schedule of Pharmaceutical Benefits).
This recommendation was implemented on 1 February 2005.
3. Registration Status
Risperdal Consta 25 mg, 37.5 mg and 50 mg were registered by the Therapeutic Goods Administration on 4 April 2003 for “the treatment of schizophrenia and related psychoses.”
4. Listing Requested and PBAC’s View
The submission requested the following listing in addition to the current Section 85 listing:
Section 100 (Highly Specialised Drug) Private hospital authority required
For the treatment of schizophrenia in patients whose illness requires supervision and treatment at hospital outpatient clinics or affiliated mental health centres.
This application was not supported by the PBAC’s Highly Specialised Drugs Working Party (HSDWP). Working party members consulted relevant areas of state health departments and hospitals in relation to this drug and advised that the section 85 listing is adequate for access for this patient and prescriber group.
5. Clinical Place for the Proposed Therapy
Risperdal Consta is a long acting atypical antipsychotic injection used for the treatment of schizophrenia in the “at risk” group of patients i.e those patients who are non-adherent, or have symptom exacerbations and/or neural toxicities, estimated to be 60% of patients. These patients are generally cared for in public hospitals, mental health centres and/or outpatients or community services.
The submission did not present a comparator as Risperdal Consta is already listed as a pharmaceutical benefit.
The additional mechanism for supply through Section 100 HSD arrangements was the basis of the submission’s request.
7. Clinical Trials
No clinical trials were presented in the submission.
The submission sought section 100 listing in addition to the current section 85 listing for risperidone long-acting intramuscular injection for patients whose illness requires supervision and treatment at hospital outpatient clinics or affiliated mental health centres.
The differentiating feature between section 100 and section 85 listing would be “at risk” versus “stabilised” patients respectively.
8. Results of Trials
Not applicable. There were no clinical trials presented in this submission.
9. Clinical Claim
The rationale presented for a dual differential listing was three-fold:
- The structure of the Australian mental healthcare system is such that treatment of schizophrenia occurs in public hospitals, mental health centres and outpatients or community services;
- The nature of schizophrenia (cognitive deficit and lack of insight) requires that some patients remain under hospital outpatient clinic care; and
- The storage requirements for Risperdal Consta make it difficult for some schizophrenia patients to comply with because of the disorganised component of their illness. T he injection must be refrigerated prior to reconstitution or stored at no more than 25 degrees C, for no more than 7 days.
10. Economic Analysis
Not applicable. There was no need to include an economic analysis in this minor submission.
11. Estimated PBS Usage and Financial Implications
The submission stated that a section 100 listing would not increase the PBS budget and predicted a cost saving in the range of $< 10 million after 4 years.
12. Recommendation and Reasons
The PBAC noted that the evidence of a problem that had been experienced with access of risperidone injection was confined to patients in NSW, principally at the Hornsby Hospital. Advice received from the Highly Specialised Drugs Working Party suggested that these problems have been resolved. Further, there was insufficient evidence to indicate that listing under the current authority required arrangements has led to non-adherence because risperidone injection has only been listed since February 2005. Furthermore, there was insufficient evidence to indicate what impact a section 100 listing would have on adherence to the drug. Although the PBAC viewed with concern the possibility of barriers to access for a vulnerable group of patients, including the issue of maintaining the cold chain, the PBAC rejected the request of the submission.
13. Context for Decision
The PBAC helps decide whether and, if so, how medicines should be subsidised in Australia. It considers submissions in this context. A PBAC decision not to recommend listing or not to recommend changing a listing does not represent a final PBAC view about the merits of the medicine. A company can resubmit to the PBAC or seek independent review of the PBAC decision.
14. Sponsor’s Comment
Janssen-Cilag will continue to monitor whether patients have acces problems under the current section 85 PBS listing