Summary of the agenda for the PBAC July 2014 meeting

Michael Wonder - Wonder Drug Consulting Pty Ltd

www.maestrodatabase.com

The PBAC will consider 50 submissions (27 major & 23 minor) at its next scheduled meeting in July (Table 1).

Table 1. Submissions by medicine type

Medicine category	Number	Percentage
PBS medicine or vaccine	41	82
PBS medicinal preparation*	7	14
NIP vaccine	2	4
LSDP medicine**	0	0

PBS =Pharmaceutical Benefits Scheme; NIP = National Immunisation Program; LSDP = Life Saving Drugs Program. * Blood reagent strips and nutritional supplements; ** Section 100 or LSDP

18 of the 50 submissions are for new medicines/vaccines (Table 2).

Table 2. Submissions by listing type

Listing type	Number	Percentage
New PBS medicine/vaccine	18	36
New indication	9	18
New combination product	5	10
New NIP vaccine	1	2
Restriction change	5	10
New strength	1	2
New formulation	10	20
Review cost-effectiveness	1	2

Some of the 13 new medicines and five new combination products are yet to be assessed/appraised by other HTA agencies (i.e. the National Institute of Health and Clinical Excellence (NICE) in England, the Canadian Drug Expert Committee (CDEC) / Expert Review Committee (ERC) in Canada and the Institute for Quality and Efficiency in Health Care or IQWiG in Germany); these are outlined in Table 3.  Interestingly, they are confined to two disease areas; obstructive respiratory disease (chronic obstructive pulmonary disease and asthma) and pulmonary arterial hypertension.

Table 3. New medicines yet to be assessed/appraised by other HTA agencies (NICE, CDEC/ERC, IQWiG)

Medicine	Sponsor	Disease/condition	Submission attempt
Empagliflozin (Jardiance)	Boehringer Ingelheim	Type 2 diabetes mellitus	Initial
Obinutuzumab (Gazyva)	Roche	Chronic lymphocytic leukaemia	Initial
Olodaterol (Striverdi Respimat)	Boehringer Ingelheim	Chronic obstructive pulmonary disease	Initial
Pomalidomide (Pomalyst)*	Celgene	Multiple myeloma	Initial
Simeprevir sodium (Olysio)*	Janssen-Cilag	Hepatitis C	Initial
Sofosbuvir (Sovaldi)*	Gilead	Hepatitis C	Initial
Umeclidinium bromide (Incruse Ellipta)	GSK	Chronic obstructive pulmonary disease	Initial
Vedolizumab (Entyvio)	Takeda	Ulcerative colitis	Initial

* These medicines are under assessment in Canada/Germany but the CDEC/IQWiG is yet to publish an appraisal.

14 (28%) of the 50 submissions are resubmissions; most are for new listings or new indications (Table 4).

Table 4. Resubmissions by listing type

Listing type	Number	Percentage
New listing	5	36
New indication	8	57
New combination product	1	7
New vaccine	1	7
Restriction change	1	7
New strength	0	0
New formulation	20	0

More than a quarter of all submissions are for medicines in WHO ATC main group L (Table 5).

Table 5. Medicines by WHO ATC main group

WHO ATC main group*	Number	Percentage
Alimentary	5	10
Blood	0	0
Cardiovascular**	2	4
Dermatological	0	0
Genitourinary	1	2
Systemic hormonal	0	0
Anti-infective	4	8
Anti-neoplastic and immunomodulatory	15	30
Musculoskeletal	3	6
Nervous	6	12
Anti-parasitic	1	2
Respiratory	5	10
Sensory	2	4
Various***	6	12

*WHO ATC = World Health Organization Anatomical Therapeutic Chemical; **The WHO is yet to allocate an ATC code to riociguat; it is been assumed that it will come under ATC main group C; **All two are medicinal preparations. 

Novartis is the leading applicant with six submissions (Table 6).

Table 6. Submissions by applicant

Sponsor	Number of submissions	Number of major submissions
Novartis (excludes Vaccines & Diagnostics Unit)	5	1
GSK	3	2
Lundbeck	3	2
Vitaflo	3	0

Submissions from new applicants are outlined in Table 7.

Table 7. Submissions from new applicants

Sponsor	Number of submissions	Number of major submissions
Merz	1	1
SWR International	1	0

Table 8. Submissions for new medicines

Medicine	Sponsor	Disease/condition	Submission attempt
Alemtuzumab (Lemtrada)	Genzyme	Multiple sclerosis	Initial
Brentuxumab vedotin (Adcetris)	Takeda	Non-Hodgkin’s lymphoma	Resubmission
Collagenase clostridium histolyticum (Xiaflex)	Actelion	Dupuytren’s contracture	Resubmission
Empagliflozin (Jardiance)	Boehringer Ingelheim	Type 2 diabetes mellitus	Initial
Glycine with carbohydrate (Glycine500)	Vitaflo	Nutrition	Initial
Ingenol mebutate (Picato)	Leo	Actinic keratosis	Resubmission
Lisdexamfetamine dimesylate (Vyvanse)	Shire	Attention deficit hyperactivity disorder	Resubmission
Lixisenatide (Lyxumia)	Sanofi	Type 2 diabetes mellitus	Initial
Obinutuzumab (Gazyva)	Roche	Chronic lymphocytic leukaemia	Initial
Olodaterol (Striverdi Respimat)	Boehringer Ingelheim	Chronic obstructive pulmonary disease	Initial
Perampernel (Fycompa)	Eisai	Epilepsy	Initial
Pomalidomide (Pomalyst)	Celgene	Multiple myeloma	Initial
Ruxolitinib phosphate (Jakavi)	Novartis	Myelofibrosis	Resubmission
Simeprevir sodium (Olysio)	Janssen-Cilag	Hepatitis C	Initial
Sofosbuvir (Sovaldi)	Gilead	Hepatitis C	Initial
Umeclidinium bromide (Incruse Ellipta)	GSK	Chronic obstructive pulmonary disease	Initial
Vedolizumab (Entyvio)	Takeda	Ulcerative colitis	Initial
Vortioxetine hydrobromide (Brintellix)	Lundbeck	Depression	Initial

Table 9. Submissions for new indications

Medicine	Sponsor	Disease/condition	Submission attempt
Abiraterone acetate (Zytiga)	Janssen-Cilag	Prostate cancer	Initial
Adalimumab (Humira)	AbbVie	Ulcerative colitis	Resubmission
Fluticasone furoate with vilanterol trifenatate (Breo Ellipta)	GSK	Chronic obstructive pulmonary disease	Resubmission
Inflximab (Remicade)	Janssen-Cilag	Ulcerative colitis	Resubmission
Panitumumab (Vectibix)	Amgen	Colorectal cancer	Resubmission
Ranibizumab (Lucentis)	Novartis	Macular oedema (DME)*	Resubmission
Ranibizumab (Lucentis)	Novartis	Macular oedema (RVO)*	Resubmission
Sorafenib tosylate (Nexavar)	Bayer	Thyroid cancer	Initial
Vildagliptin, vildagliptin with metformin hydrochloride (Galvus/Galvumet)	Novartis	Type 2 diabetes mellitus	Resubmission

* DME = diabetic macular edema; RVO = retinal vein occlusion

Table 10. New combination products

Medicine	Sponsor	Disease/condition	Submission attempt
Dapagliflozin propanediol monohydrate with metformin hydrochloride (Xigduo)	AstraZeneca	Type 2 diabetes mellitus	Initial
Ezetimibe with rosuvastatin calcium (Rosuzet)	MSD	Hypercholesterolaemia	Initial
Indacaterol with glycopyrronium bromide (Ultibro Breezhaler)	Novartis	Chronic obstructive pulmonary disease	Resubmission
Mifepristone with misoprostol (MS-2 step)	Marie Stopes Health	Contraception	Initial
Umeclidinium bromide with vilanterol trifenatate (Anoro Ellipta)	GSK	Chronic obstructive pulmonary disease	Initial

Table 11. “Selected” new formulations*

Medicine	Sponsor	Disease/condition	Submission attempt
Incobotulinumtoxin A	Merz	Muscle spasticity	Initial