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PregabalinADIRAMEDICA PREGABALIN

Not recommended NeurologyNot applicableNot applicable line 💬 consumer voice

Treatment of neuropathic pain in adults. The submission sought listing of an oral solution formulation under the same conditions as currently PBS-listed pregabalin capsules.

8
Submissions
3 resub
2005–22
On the record
$15k
ICER range
2 sourced ICERs · 2005–2011
Cost-min
Cost basis

Decisions on record

6 decisions
  • Meeting May 2022 Not recommended Neuropathic pain in adults, refractory to other drugs no PSD
  • Meeting May 2022 Not recommended Neuropathic pain no PSD
  • Meeting Nov 2021 Deferred Neuropathic pain
  • Meeting Nov 2021 Deferred Neuropathic pain
  • Meeting Mar 2012 Recommended Neuropathic (nerve) pain
  • Meeting Mar 2011 Not recommended Neuropathic (nerve) pain

Access path

8 submissions · public record
  1. TGA registered · ADIRAMEDICA PREGABALIN

    TGA label narrower than the PBS population

  2. Jul 2005
    Recommended · restricted

    vs gabapentin

  3. Mar 2011
    Not recommended

    uncertain cost effectiveness, uncertain transition probabilities from Community Study, unconvincing utility data and…

  4. ↻ resubmitted
    Mar 2012
    Recommended · restricted

    Evidence: RCT, Single-arm, Registry → RCT, Meta-analysis

  5. Mar 2012
    Recommended · restricted

    Evidence: RCT, Single-arm, Registry → RCT, Meta-analysis

  6. Nov 2021
    Deferred

    Comparator changed: amitriptyline → pregabalin capsules (currently PBS-listed)

  7. Nov 2021
    Deferred

    Comparator changed: amitriptyline → pregabalin capsules (currently PBS-listed)

  8. May 2022
    Not recommended

    Comparator changed: pregabalin IR (immediate release) → pregabalin IR (immediate release)…

  9. May 2022
    Not recommended

    lack of established clinical need for an oral liquid formulation (capsule contents can be dispersed in water/food for…

RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
The PBAC deferred making a recommendation for the listing of a controlled-released formulation of pregabalin (pregabalin CR) for the treatment of neuropathic pain to allow for utilisation analysis of immediate release pregabalin (pregabalin IR) and to further consider the potential quality use of medicines (QUM) issues with the CR formulation.PSD · Nov 2021
The PBAC was concerned about reports of potential misuse and diversion of pregabalin (and gabapentinoids more broadly) in Australia. The Committee therefore considered it was prudent to review the utilisation of pregabalin and to consider current evidence of misuse and diversion of pregabalin in Australia prior to forming a view as to whether other forms of pregabalin should be recommended for listing on the PBS.PSD · Nov 2021
Economic analysis
No formal economic analysis was presented in the submission; rather, the PI daily dose relativity (1.1 : 1 pregabalin CR : pregabalin IR) was implicitly assumed to represent equi-effective doses, and the proposed pricing of pregabalin CR 82.5 mg tablets, 165 mg tablets and 330 mg tablets was directly based on the price of pregabalin IR 75 mg capsules, 150 mg capsules and 300 mg capsules, respectively (converting current 28-day supply to proposed 30-day …PSD · Nov 2021
The submission matched the daily price of the CR formulation to the 1.1: 1 equivalent IR capsule strength, not the IR total daily dose (TDD). Given the IR is dosed twice daily, 9PSD · Nov 2021
Clinical claim
No explicit clinical claim was presented in the submission. However, the submission stated that a cost minimisation approach was taken to establish the pricing of pregabalin CR tablets relative to the currently listed pregabalin IR capsules. This is consistent with a claim of non-inferiority.PSD · Nov 2021
The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonably supported by the data.PSD · Nov 2021
Consumer comments
The PBAC noted the advice received from Musculoskeletal Australia outlining three patient experiences of being treated with immediate release pregabalin. All three patients offered minimal support for listing of pregabalin CR due to the negative side effects and limited benefits of pregabalin treatment for pain.PSD · Nov 2021
5.4 The submission used a market share approach to estimate the uptake and financial implications of Pregabalin-AFT. The submission stated that Pregabalin-AFT is not expected to increase market size or growth and that only a fraction of patients will switch from using capsules to oral liquid.PSD · Nov 2021

Cost-effectiveness

2 sourced ICERs · 2005–2011

Cost-minimisation analysis; no ICER calculated. Submission was Category 4 and pricing comparison showed Pregabalin-AFT was cost-competitive only versus 25 mg and 75 mg capsules, not the higher-strength formulations.

The PBAC considered that there was a potential for market growth if Pregabalin-AFT was listed on the PBS as there may be patients not currently on pregabalin capsules who would utilise an oral liquid formulation. PBAC · 2022
ICER uncertainEconomic model disputedIndirect comparison

Decision context

PopulationAdults with neuropathic pain requiring pregabalin therapy.

Why it was knocked back

  • lack of established clinical need for an oral liquid formulation (capsule contents can be dispersed in water/food for swallowing difficulties), quality use of medicines concerns (misuse and diversion of pregabalin, concomitant use with opioids and benzodiazepines associated with respiratory depression and mortality, potential for increased misuse and overdosing with oral liquid formulation), evidence of use outside PBS restrictions

Submission history

8 entries
DecidedOutcomeComparatorICEREvidence
May 2022 Not recommended pregabalin IR (immediate release) capsules — RCT · Loss of therapeutic response
May 2022 Not recommended pregabalin capsules (currently listed) — Cost-minimisation · Cost-minimisation
Nov 2021 Deferred pregabalin capsules (currently PBS-listed) — Cost-minimisation · Cost-minimisation
Nov 2021 Deferred pregabalin IR (immediate release) — RCT
Mar 2012 Recommended · restricted amitriptyline — RCT, Meta-analysis · mean change in pain score from baseline, responder rates (≥50% reduction in pain scores from baseline) and mean Patient Global Impression of Change (PGIC) score
Mar 2012 Recommended · restricted amitriptyline — Meta-analysis
Mar 2011 Not recommended amitriptyline $15k RCT, Single-arm, Registry
Jul 2005 Recommended · restricted gabapentin $15k RCT

Consumer voice

May 2022

Three patients with experience of immediate release pregabalin provided feedback through Musculoskeletal Australia, expressing minimal support for listing of pregabalin CR due to negative side effects and limited benefits of pregabalin treatment for pain.

All three patients offered minimal support for listing of pregabalin CR due to the negative side effects and limited benefits of pregabalin treatment for pain. Consumer comments · PSD
side effectslimited efficacytreatment burden

Similar precedents

By decision profile
Lignocaine75%Paracetamol67%Buprenorphine65%Tapentadol65%Perampanel66%Zonisamide65%Topiramate65%Lacosamide65%

Regulatory · TGA

Label narrower than PBS population — PBAC restricted PBS subsidy to neuropathic pain only, excluding the TGA-registered seizure indication.

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