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Restriction of BCG Supplies

Information and advice from BAUS, BAUN, Fight Bladder Cancer & Action Bladder Cancer UK

03 December 2021 (Last updated: 11 Dec 2021 07:59)

Background

Due to limited worldwide supplies of OncoTice BCG®, Merck Sharp Dohme Ltd (MSD) are no longer able to fully support the UK market for the foreseeable future.  The Department of Health and Social Care (DHSC) Medicines Supply Team have been working with MSD to ensure that the limited supplies that will be made available in the UK are distributed equitably to hospitals.  Currently 90% caps on supplies are being implemented by wholesalers. The health service is likely to remain vulnerable to fluctuations in supply and it is anticipated that this fragile supply situation will exist until 2025 by which time expanded manufacturing capacity will be available.

OncoTice BCG® is the only licensed BCG bladder instillation product in the UK.  Although other strains of BCG are in use throughout the world, they are not licensed in the UK. 

Given the recurring issues with BCG supplies, BAUS has taken a number of steps to try and minimise the problems this will cause:

  • we have performed a further review of the evidence for all alternative treatment options; 
  • we have sought the views of key international opinion leaders in this area; 
  • we have consulted with BAUN and bladder cancer charities (Fight Bladder Cancer and Action Bladder Cancer UK) in production of this consensus guidance; and
  • we have liaised with DHSC Medicine Supply Team and MSD and we will explore and lobby for diversification of the UK’s BCG supply.

General recommendations

The situation is clearly distressing for patients with high risk non-muscle invasive bladder cancer (HRNMIBC) who are already undergoing BCG treatment and for those who have been recently diagnosed.

It is important that all patients with HRNMIBC are counselled appropriately and reassured that their care will not be substantially compromised.  If the treatment recommendations outlined below are followed, all patients with HRNMIBC, for whom BCG would normally be the recommended first-line option, should be able to receive effective evidence-based treatment. 

In general terms:

  • management of HRNMIBC with TURBT then cystoscopic surveillance alone is not appropriate, even if local BCG supplies have run out these patients should always be offered an alternative (see below); 
  • as should already be the case, all patients with HRNMIBC should be discussed at their regional Specialist bladder MDT meeting Ref 1;
  • patients should be counselled that radical cystectomy (RC) is an alternative option to BCG therapy, but NOT the only option available in this setting;
  • previous consensus advice about utilisation of 1/3 dose or reduced frequency dosing of BCG should be disregarded, following the negative outcome of the NIMBUS trial Ref 2; and
  • if BCG supplies become severely restricted, those with highest risk disease (eg G3pT1 and pTis) should be prioritised over those with lower risk disease (eg G3pTa).

Specific Clinical Recommendations

As per Improving Outcomes Guidance Ref 1, individual patients should be reviewed in a specialist bladder cancer clinic and have their disease risk stratified.  The risks and benefits of the active treatment options of intravesical BCG therapy, or cystectomy and urinary diversion, should be discussed, considering an individual’s disease risk and co-morbidities.   If the shared decision is reached to proceed with intravesical BCG therapy then the following guidance should be considered, click here to see the flow chart, "Streamlining BCG Usage".

Risk stratification by disease severity and BCG availability

SCENARIO A - STANDARD HRNMIBC (G3pTa alone)

Routine supply give induction BCG and up to 2nd batch of 3 doses of maintenance BCG
Limited supply give induction BCG and up to 2nd batch of 3 doses of maintenance BCG, if available 

if 2nd batch of 3 doses of maintenance BCG not available, consider intravesical mitomycin C chemotherapy (assisted with hyperthermia or electromotive delivery if locally available) Ref 3.
Supply unavailable offer (assisted) intravesical mitomycin C chemotherapy +/- maintenance treatment * (see below)
* Patients receiving (assisted) mitomycin C chemotherapy should be counselled that treatment reduces the risk of disease recurrence but not progression

SCENARIO B - VERY HRNMIBC (G3pT1 +/- pTis)

Routine supply give induction BCG and up to 8th batch of 3 doses of maintenance BCG
Limited supply give induction BCG up to 2nd batch of 3 doses of maintenance BCG.  Patients who have reached years 2 and 3 of maintenance should be counselled that this is safe in terms of progression Ref 4, although there is a slightly higher risk of recurrence in the very highest risk HRNMIBC patients; or

excluding patients with pTis, following induction and up to 2nd barch of 3 doses of maintenance BCG therapy, offer (assisted) mitomycin C chemotherapy, or alternative maintenance intravesical chemotherapy (e.g. epirubicin); or

consider induction treatment with intravesical gemcitabine chemotherapy Ref 5.
Supply unavailable excluding patients with pTis, consider induction & maintenance therapy with (assisted) mitomycin C chemotherapy; or

consider induction treatment with intravesical gemcitabine chemotherapy ** (see below)
** Patients receiving alternative chemotherapy should be counselled that treatment reduces the risk of disease recurrence but not progression

Finally, patients already on BCG therapy who fail treatment should not be offered a further course of induction BCG (as has been an option in the past), but should consider radical cystectomy (if fit) or (assisted) intravesical chemotherapy if they are unsuitable or unwilling to undergo radical cystectomy.

References

  1. National Institute for Health and Care Excellence - Improving Outcomes in Urological Cancers. https://www.nice.org.uk/guidance/csguc/evidence/improving-outcomes-in-urological-cancers-manual-2 (accessed Sept 2021).
     
  2. Grimm MO, van der Heijden AG, Colombel M et al. Treatment of High-grade Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial "NIMBUS". Eur Urol 2020;78:690-698.
     
  3. Tan WS, Panchal A, Buckley L et al.  Radiofrequency-induced Thermo-chemotherapy Effect Versus a Second Course of Bacillus Calmette-Guérin or Institutional Standard in Patients with Recurrence of Non-muscle-invasive Bladder Cancer Following Induction or Maintenance Bacillus Calmette-Guérin Therapy (HYMN): A Phase III, Open-label, Randomised Controlled Trial. Eur Urol 2019;75:63-71.
     
  4. Oddens J, Brausi M, Sylvester R et al. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guerin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol. 2013;63:462-472.
     
  5. Jones G, Cleves A, Wilt T et al. Intravesical gemcitabine for non-muscle invasive bladder cancer.  Cochrane Database Syst Rev 2012 Jan 18;1:CD009294.

Links

Action Bladder Cancer (ABC) UK  |  BAUN  |  Fight Bladder Cancer (FBC)

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